By David Brown
Washington Post Staff Writer
Wednesday, June 19, 2002; Page A01


Antibiotic prescriptions for children fell by 40 percent over the course of the 1990s, reversing an upward trend that had fueled the emergence of hard-to-treat, drug-resistant bacteria, researchers reported yesterday. The dramatic reversal was seen across the spectrum of common ailments of childhood, including ear infections, sore throats, bronchitis and miscellaneous respiratory infections. It was seen in all ways that drug prescribing is gauged -- total number of prescriptions, prescriptions per child and prescriptions per trip to the doctor.

The change follows numerous public health campaigns aimed at doctors and parents, widespread media coverage of "super-bugs" and a few documented examples of death from bacterial infections that once would have been easily cured. "It's a dramatic decline," said Linda F. McCaig, an epidemiologist at the National Center for Health Statistics, the organization that regularly surveys the prescribing behavior of American physicians. "It's encouraging that parents and physicians may be getting the message about how to use antibiotics appropriately."

The national survey results appear in today's Journal of the American Medical Association. Accompanying them is a report on a successful 1997 campaign to lower antibiotics use in Knoxville, Tenn., the American city with the highest per capita use of prescription drugs in the country. That campaign featured a number of strategies, including lectures to doctors and handouts to parents of newborns. It produced a drop in antibiotic prescription-writing over the next two years that was more than double that seen in three other Tennessee cities -- 19 percent vs. 8 percent.

"We think this can serve as a model for community-wide interventions in other places," said Allen S. Craig, Tennessee's state epidemiologist. Neither the national nor the local study measured the effects on children's health -- good or bad, or none at all -- from the decline in antibiotic use. However, in Knox County (Knoxville and its suburbs), there was no increase in serious infections from Streptococcus pneumoniae -- the most common bacterial pathogen in young children -- said Stephanie Hall, the county health officer. There also wasn't a decrease in the prevalence of drug-resistant strains of the bacterium, although that is likely to take longer to occur.

Most antibiotics used in the United States are prescribed in doctor's offices. Usually they are for infections for which the practitioner isn't certain what microbe is responsible. The proliferation of antibiotics, and the cultural perception that taking them is the safer course in situations of uncertainty, has led to a steady rise in their use over the last 30 years, peaking in 1992. At that time, American children under age 15 got, on average, one antibiotic prescription a year. Many studies have shown, however, that when definitive diagnostic tests are performed, most upper respiratory infections are caused by viruses, not bacteria. Viruses are not killed by antibiotics.

Several experts said it is unclear whether the decline seen in the two studies will last. "We know from the experience in other countries that when you are on top of things, you can control prescribing," said Stuart B. Levy, a physician at Tufts University School of Medicine, who founded the Alliance for Prudent Use of Antibiotics in 1981. "But once you leave, there's a great temptation to go back to the old behavior. So, reminders will be needed."

In the National Ambulatory Medical Care Survey, about 3,000 office practitioners are asked to record patient visits, and what they prescribe, for a week. The sample is chosen to represent the country statistically.

In the 1989-1990 survey, the average annual number of antimicrobial drugs prescribed in offices to children under age 15 was 45.5 million. In 1999-2000, it was 30.3 million. The rate of prescription per 1,000 visits fell from 838 to 503 -- a decrease of 40 percent. The rate at which trips to the doctor by children resulted in antibiotic prescriptions fell from 330 per 1,000 visits to 234 per 1,000 visits -- a decrease of 29 percent.

This last measure is the best window on what is happening in the doctor's office -- where a complicated interaction of the patient's ailment, the physician's judgment and knowledge, and the parent's expectation determines behavior, McCaig said. The Knoxville campaign began after three children in a day-care center in nearby Morristown developed meningitis caused by multi-drug-resistant S. pneumoniae in one week in 1996. One died.

A physician from the Centers for Disease Control and Prevention was invited to talk to 150 key physicians in Knox County. Prescribing guidelines were sent to 250 doctors, 40,000 pamphlets were given to parents of toddlers and young grade-schoolers, and 53,000 pamphlets were handed out to pharmacy customers.


© 2002 The Washington Post Company

Think about this:
a. The number of physicians in the US is 700,000.
b. Accidental deaths caused by Physicians per year is 120,000.
c. Accidental deaths per physician is 0.171. (US Dept. of Health & Human Services)

Then think about this:
a. The number of gun owners in the US is 80,000,000.
b. The number of accidental gun deaths per year (all age groups) is 1,500.
c. The number of accidental deaths per gun owner is .0000188.

Statistically, doctors are approximately 9,000 times more dangerous than
gun owners.

FACT: NOT EVERYONE HAS A GUN, BUT ALMOST EVERYONE HAS AT LEAST ONE DOCTOR.

 

When Modern Medicine Fails


By Charles Krauthammer
Friday, July 12, 2002; Page A21


In "Sleeper," Woody Allen wakes up a couple of hundred years in the future to discover, among other things, that scientists have found that tobacco is actually good for you. Well, not quite yet. But how about eggs? After years of egg phobia, we have learned that eggs may not be bad for you after all. And that butter is healthier than stick margarine. Every month, it seems, some accepted nutritional fact is overturned.

We have come to expect that diet fashions, though promulgated with scientific authority, change like the seasons. What we do not expect is a change in hormone fashions. Hence the shock this week when a massive study of hormone replacement therapy in postmenopausal women had to be halted three years early because the estrogen-progestin combination appeared to cause an alarming increase in invasive breast cancer, blood clots, strokes and heart attacks.

With that, the decades-old medical axiom about the protective powers of  hormonal therapy was overturned in a flash. The reverberations were immediate. The company whose pill was being tested, Wyeth Pharmaceutical, lost 24 percent of its value in one day. Millions of women are now frantically calling their doctors for advice on whether to continue.

Most shocking, perhaps, is the simple reminder of how contingent are the received truths of modern medicine. We know how pre-modern medicine got it wrong, from centuries of leeching and bleeding to the lobotomies and shock therapies that destroyed the lives of so many psychiatric patients in the mid-20th century. But we think of modern science as infinitely more enlightened and more solid.

Not so. Less than a century ago, the most exalted scientific theory, Newtonian mechanics, was overthrown. Today its successors, general relativity and quantum mechanics, have yet to be fully reconciled. Thirty years ago, the scientific consensus was that we were headed for global cooling. Today it is global warming. The only thing I feel reasonably sure about is that 30 years from now meteorological science will have delivered yet a new theory, a new threat, a new thrall.

The problem is that even the most sophisticated scientific studies are limited by method, by modeling, by sampling and by an inevitable margin of error. Hence error and revision. In medicine, because its solemn pronouncements are so widely propagated and so ingrained in people's lives, these revisions are particularly shocking. Yet common. When I was a kid, everyone got a tonsillectomy. It was a rite of passage. We now know that this was unnecessary surgery, indeed, worse than useless. We also routinely were given antibiotics for earaches. It now turns out that this did not hasten recovery, and in fact may have made us, and the population in general, more resistant to antibiotics.

For decades, breast cancer was treated with radical mastectomy, a disfiguring and deeply invasive surgery. The idea that many patients should instead be treated with lumpectomy was ridiculed for decades. It is now accepted medical practice. My favorite myth is 98.6. If there was anything solid in my medical education, it was that mean body temperature was 98.6 F. Well, in 1992 the Journal of the American Medical Association published a study that actually measured it. It turns out to be 98.2 degrees. Where did the 98.6 come from? From the German doctor, Carl Wunderlich. In 1868. No
one had bothered to check it since then.

The myths go on and on. That infectious diseases had been conquered. (Then came HIV.) That asthma is a psychological condition. That ulcers are caused by stress or stomach acid. For decades at mid-century, at the height of the psychoanalytic fad, the cream of the New York intelligentsia was sending its healthy children to five-day-a-week psychoanalysis.

So much nonsense. So much damage. Yet science has a hard time with humility. The rage today is regenerative medicine. Stem cells. Cloning. The growing, essentially, of replacement parts. It sounds wonderful, and it may yet turn out to be.

It is well to remember, however, that this is not the first panacea to be peddled. Yesterday, it was fetal tissue transplants for degenerative diseases and angiogenesis inhibitors for the cure of cancer. All of which looked wonderful on paper but have not panned out. This is not to say that this embryonic research will not pan out. It is only to say that when you hear Sen. Dianne Feinstein tell you that the research cloning her bill would promote will do wonders for your suffering Aunt Sarah, hold on to your wallet. She's talking about the speculative benefits from the most speculative of new technologies --at a time when, until yesterday, science could not tell us the effects of existing postmenopausal hormone therapy on known medical conditions. For now, I'll put my money on Woody Allen. "Sleeper" discovers that hot-fudge sundaes turn out to be good for you too.

© 2002 The Washington Post

 

www.medscape.com/viewarticle/442631?mpid=4825

NEW YORK (Reuters Health) Oct 07 - One in 10 children who are treated in the emergency department (ED) may get the wrong dose of medicine or be given medication at the incorrect frequency, new study findings suggest. Children seen between 4 AM and 8 AM, children with severe disease and those seen on weekends were between 1.5 and 2.5 times more likely to experience a medication prescribing error than others, lead author Dr. Eran Kozer, from the Hospital for Sick Children in Toronto, and colleagues note.

In their paper in the October issue of Pediatrics, Dr. Kozer and colleagues note that between 44,000 and 98,000 people die each year in the US as a result of medical errors. And prescribing errors, they note, occur most frequently in pediatric patients and EDs.

Dr. Kozer's team reviewed the medical records of 1532 children treated in the ED of a pediatric hospital. Two pediatricians independently decided whether a medication error had occurred and gave errors a numerical severity score.

"Prescribing errors were identified in 10.1% of the charts," the researchers report.

"The most common types of prescribing errors were dosing errors, followed by drugs given with incorrect frequency," they add.

Drugs most commonly implicated in prescribing errors included acetaminophen, antibiotics, asthma medications and antihistamines.

"Our findings suggest that errors are more common among seriously ill patients and that trainees are more likely to make medical errors, particularly at the beginning of the academic year," the authors write.

"Future research should focus on the development and evaluation of strategies to reduce medication errors in the pediatric emergency department," they conclude.

Pediatrics 2002;110:737-742.

 

http://publhealth.annualreviews.org/cgi/content/abstract/23/1/135

Annu. Rev. Public Health 2002. 23:135-150.

MORBIDITY AND MORTALITY FROM MEDICAL ERRORS: An
Increasingly Serious Public Health Problem

David P. Phillips and Charlene C. Bredder

From 1983 to 1998, U.S. fatalities from acknowledged prescription errors increased by 243%, from 2,876 to 9,856. This percentage increase was greater than for almost any other cause of death, and far outpaced the increase in the number of prescriptions. Many nonfatal prescription errors also occur, but estimates of the frequency of these errors vary widely, because various definitions, geographic settings, and institutions have been used. Efforts to reduce fatal and nonfatal prescription errors have encountered perceptual,  legal, medical, and cultural barriers. It may be possible to reduce prescription errors by instituting a central agency responsible for collecting, analyzing, and reporting harmful or potentially harmful drug events, and for issuing recommendations and directives.

SOURCE: http://www.newswithviews.com/health_care/health_care4.htm

GANGSTERS IN MEDICINE
 
By Thomas Smith
December 23, 2002

The Journal of the American Medical Association recently reported that as many as 106,000 deaths occur annually in US hospitals due to adverse reactions to prescription drugs that are properly prescribed by physicians that use them as directed by the drug companies.  Even worse, the National Council for Patient Information and Education reported that an additional 125,000 deaths occur annually due to adverse reactions to drugs that the physician never should have prescribed. In these deaths the doctor did not follow the instructions on proper administration of the drugs. For example, Glucophage, a diabetic oral hypoglycemic, should never be prescribed for patients with Kidney disease or Congestive Heart Failure because it can cause fatal Lactic Acidosis in these patients. A warning label is prominently placed on the medication container to warn of this potential misuse. 

    However, JAMA reported that almost 1/4 of the patients who had been prescribed Glucophage had Kidney damage or Congestive Heart failure or both. The annual death toll from synthetic prescription drugs, both from the correctly prescribed and the incorrectly prescribed, amounts to about 231,000 deaths every year. To put this into perspective, this is the equivalent of a world trade center disaster every week for over a year and a half or the crash of two fully loaded 747 aircraft every day of the year.  

    No information was reported on the number of outpatient and doctor's office deaths caused by these very same drugs when prescribed by these very same doctors. The reported figures alone, however, make drug deaths caused by physicians the third leading cause of death in the US. It is far ahead of accidents, drunk driving, homicides, airline accidents, as well as all other disease with the sole exceptions of cancer and heart disease. Many of these drugs responsible for the death statistics cited are diabetic drugs. None of these drugs cure or even were intended to cure diabetes.
During the time a patient is on the drugs his body is suffering great damage due to the uncontrolled progress of the disease. This is in addition to the risk and damage caused by the drug itself.
 
    According to Dr. Mendelsohn, author of "Confessions of a Medical Heretic", 2.4 million unnecessary operations are performed every year and they cost over 12,000 lives. When the records of six New York hospitals were examined it was found that 43% of the Hysterectomies that were performed were medically unnecessary.  No one should ever submit to any surgical procedure without first obtaining several unrelated medical opinions, at least not here in the United States. Women are particularly vulnerable to this type of victimization. 

Disease in America
    According to the World Health Report 2000 the United States ranks twelfth, that is second from the bottom, in their thirteen country survey of sixteen available health indicators. We are dead last for low birth weight and neonatal and infant mortality. We rank between ninth and twelfth for all life expectancy categories between one year and 40 years. Another study ranked the United States as fifteenth in the twenty-five industrialized countries studied. 

    Diabetes, Hypoglycemia, Hyperinsulinemia are so widespread in the United States that it is estimated that over half the population exhibits one or more symptoms of these life destroying diseases. Symptoms of Adult onset diabetes are now being routinely noted in six year old children. Obesity and it's related Endocrine dysfunction are commonly observed in teenagers. Heart  Failure, a symptom of advanced Type II Diabetes, remains in the top three killer diseases in the Westernized countries.   Although the cause and cure for Type II Diabetes and related endocrine failure has been increasingly well understood in the scientific community for the last forty years, this disease is not being cured by todays orthodox treatment regimens. In order to find a cure it is necessary to seek alternative medical approaches to this disease. 

Some of the economics of Medicine
 
A large part of this medical disaster that the United States currently experiences is due to the way our medical community is organized. Basically it is not organized to heal and to cure disease; the medical community, particularly at its upper levels, is a commercial venture organized to make money for its practitioners. 

    Although the record of the United States Medical community in the cure of disease is deplorable, the same cannot be said for its ability to produce income and profit. For example, for the top fifteen pharmaceutical companies, including such names as Abbot, Wyeth, Hoffman-La Roche, Merck and others, the second quarter revenue for 2002 was reported as $63,520.6 million and the corresponding reported income was 11,731.8 million respectively. This is second only to the defense industry in the United States.  In 1997, the latest year for which we have the figures, the earnings of physicians were reported by Broad as averaging around $200,000 per year. The lowest reporting specialty, Rheumatology reported $158,500 and the highest, cardiovascular surgeon, reported $363,300. When examining the numbers, we noted that the high salaries seemed to be concentrated in members of the AMA. Those belonging to less powerful trade unions did not fare nearly so well even though they did most of the actual patient care work. For example, the median staff salary of registered nurses was $35,256 

    The Cardiac surgeon, for example, does nothing whatsoever to cure cardiac disease. Three to five percent of the heart surgery patients die on the operating table. Cardiac surgery provides no better three year survival rate than no treatment at all. A Harvard survival study of 200,000 patients revealed that the long term survival rate of patients subjected to surgery was no better than the survival rate of those that had no surgery.   Of course, your cardiac surgeon will not tell you this when you need to make a decision on whether or not to elect cardiac surgery.  Never in history have so many accumulated so much wealth for providing their customers or clients or patients with so little real benefit. 

Exceptions to the rule
     
Many doctors of integrity are as much victims of the system as are their patients. Todays doctor is not free to treat disease as his conscience dictates. He is forced to administer approved protocols whether they are known to work or not. To deviate from these approved protocols invites law suits, peer criticism and censure from State medical licensing boards.  This writer knows of two local doctors who tried to buck the establishment and really help their patients. Both lost their license to practice medicine. One is currently working as an administrator in a California hospital and the other has started a nutritional clinic. 

Takeover of the American medical Association

This sad state of affairs is directly traceable to the takeover of the American Medical Association by the Carnegie and Rockefeller foundations in the early part of the twentieth century.   At the turn of the century the medical community was in a sad state of disrepair. There were no qualifications to become a doctor. If one wanted to be a doctor it was only necessary to hang out a shingle and start the practice of medicine. Medical schools were poorly financed, often taught contradictory medical philosophies and had little impact on the practice of medicine. In 1910 the American Medical Association, todays AMA, was on the verge of bankruptcy. Few doctors belonged to it and even fewer paid any attention to it. Quackery of all kinds was rampant. The market was flooded with fake cancer cures and 80 proof liver tonic.  

    It was in this environment that Rockefeller and Carnegie moved in and bought the AMA and then used it to take control of the entire United States medical establishment. In 1910, Henry Prichard president of the Carnegie foundation, bought control of the AMA for the sum of $10,000. He then  financed the publication of the Flexner report, as it was then called, to gain popular support for the changes that were to be made in the medical community. With public backing secured by the publication of the Flexner report, Carnegie and Rockefeller commenced a major upgrade in medical education by financing only those medical schools that taught what they wanted taught. Predictably, those schools that had the financing churned out the better doctors. 

    In return for the financing, the schools were required to teach course material that was exclusively drug oriented. That is why today our doctors are so heavily biased toward synthetic drug therapy and know little or nothing about nutrition.  Dr. David Edsall, former dean of Harvard medical school, said "I was, for a period, a professor of Therapeutics and Pharmacology, [at Harvard] and I knew from experience that students were obliged then by me and by others to learn about an interminable number of drugs, many of which were valueless, many of them useless, some probably even harmful...."
 
   For a time, these changes actually improved the practice of medicine in the United States. Then, as the distorted medical curriculum began to churn out doctors whose only concern was prescribing synthetic drugs, things began to deteriorate into what we see today.  Today the average medical doctor receives 3 hours or less training on nutrition despite the fact that our bodies are constructed entirely of what we eat and drink. Todays doctor receives much of his ongoing education from detail men. The detail man is the drug company salesman whose job it is to teach the doctor how to use the latest drugs.

 Treatment instead of cure

 Even with all of this history the medical doctor retained a great deal of his autonomy through the 1930's and into the late 1940's. In 1949 another major change took place in the medical community that set the stage for the disaster we see today. It was in 1949 that the medical community reorganized itself into the competing medical specialty groups we see today. Prior to 1949 a doctor was a doctor; he dealt with all disease and injury. After 1949 this was not so.  The reorganization established many of the specialties that we know today. It was then that the Cardiac Specialist, the Endocrinologist, the Hepatic and Biliary Specialist and many other professional specialty groups were formed. The symptoms of the then raging epidemic of Type II Diabetes were divided among the specialty groups so that each group had their own set of  proprietary symptoms. 

The story given out for the reorganization was that it would help to focus more attention on the then current Diabetes epidemic. However, in practice it caused the entire medical community to treat their own proprietary symptom set and nobody focused on curing the disease anymore. This was the origin of the "treat the symptom" and "ignore the cause" philosophy that now dominates  the entire medical community.   This was the turning point event that led to the removal of the word "cure" from the medical vocabulary. Today, if you mention the "c" word around your doctor he will usually glaze over and pretend not to hear you. He only responds to the word "treatment". 

    Under the Rockefeller and Carnegie influence their pharmaceutical firms started to pour out the vast array of synthetic drugs that the doctors trained to their medical school standards now prescribed almost to the exclusion of any other remedies. Among the first drugs to be marketed this way were the oral hypoglycemic agents. They were deliberately designed to treat the symptom while not curing the disease. 

Insurance fraud

Since the name of the medical game was money, a means had to be devised to provide the patient with money that could only be used to pay for approved medical treatment. Enter the insurance company concept. Today employees have, as an important part of their remuneration for their work, a health insurance policy. This health insurance policy does not pay for all health related needs; it only pays for those health related services that are approved. These, of course, are the synthetic drug therapies that are known to work poorly, if at all.  In order to secure effective medical treatment from the alternative sector ofthe economy the patient must pay for it himself; insurance companies specifically exclude virtually all alternative treatment. One wonders why so many continue to pay for an insurance program that cannot, even in principle, be of any real benefit to them. 

Government coercion in medical practice

In the ordinary course of events, good medicine would eventually drive out bad medicine. As more and more people discover ways to maintain and improve their health, without drug therapy, they will simply abandon bad medicine and resort to alternative therapies.  Indeed, this is happening. Also happening is a concerted government effort to discredit and declare unlawful those effective therapies that represent the greatest threat to orthodox medicine. In the last fifty years many effective cures have been developed for many of the major killer diseases that we have. In each instance the developer has been branded a quack, his business has been ruined and in some cases he has been sent to jail. 

    Even with outright governmental attacks on those that would promote effective therapies in America, the tide is turning. More and more Americans are waking up to the reality of our medical community. More and more they are finding it to be a fraud and they are turning to less conventional treatments and modalities.  Informed Americans that require effective medical treatment for anything more serious than a head cold are turning away from orthodox drug quackery in droves. The medical community is trying hard to make it illegal to refuse their treatment. A major effort is currently underway (Codex) to severely restrict the availability of nutritional supplements to those that use them throughout the world. Our government is seriously considering mandatory vaccination programs. 

    Many believe that our Food and Drug Administration, FDA, represents the American people and that the FDA acts to insure that our food and drugs are safe and effective. Nothing could be further from the truth. The FDA acts entirely to restrain and manage competition between and among those that manufacture our food and drugs. They do this only for the purpose of  minimizing competition in business. Rockefeller is famous for proclaiming the only sin is competition.  Willy Ley, a former head of the FDA, said it best when he said "What the Food and Drug Administration does and what the public thinks that it does are a different as night and day". 

    Today in America the practice of medicine is not free. It is one of the most tightly controlled commercial enterprises in the world. That is why it produces such extraordinary income for it's favored and such misery, disease and death for its victims. 

What to do

Given the growth of the medical monster that ate the United States, what can we who live here do to effectively manage our own health. Perhaps the single most important thing that we all must do is to recognize that our health is our most important possession. We have no choice but to  accept total responsibility for our own health. To leave such an important consideration to someone who clearly has much to gain by lying to us just does not make sense. Typically, we buy our cars and houses with a great deal more wisdom than we bring to the doctor's office when we go there.      The modern orthodox medical community treats symptoms; they do not cure disease. When you visit the doctor, it is perfectly in order for you to ask bluntly whether or not the treatment he wants to give you will cure the disease you have.  Some years ago, when I had a serious case of Type II Diabetes, I asked my doctor that question about the treatment he offered me. First he pretended he did not hear me. When I persisted and made eye contact and repeated the question he replied "this is the prescribed treatment". Such an evasive answer to such a direct question sent me to the library where I did the research to get a better answer. I quickly discovered that the drug he offered me would not only not cure the disease, but that it was guaranteed to put me on the road to becoming an invalid long before my time. Fortunately I rejected his treatment. I went on to search the scientific literature where I quickly found what I needed. It had nothing to do with synthetic drugs. It took me about 3 1/2 months to fully reverse my diabetes. That was seven years ago. The disease remains in full remission to this day. 

    There is one important caveat that must be mentioned at this point. If you are currently under a doctors care and are dissatisfied with the results you are getting, do not just stop taking the prescribed medication. Get your doctor, or another doctor if yours will not cooperate, to help weanyou off prescription drugs and to help you to devise a workable alternative therapy. Many of these synthetic drugs will produce serious side effects if they are  abruptly discontinued. When I had the problem I had not yet taken prescription medication. 

    After accepting full responsibility for your own health, the second most important consideration is to do your homework and learn about the disease or disability that you have. Buy books, attend seminars, subscribe to newsletters, search the internet, learn about what it takes to actually reverse the disease that afflicts you. Investigate alternative medical practitioners. Many Naturopaths and Chiropractors can be of great help in actually curing disease. Do not fall for the idea that only doctors are smart enough to understand these things.   Look for that unusual doctor that will risk really trying to help you; and, realize that he is taking a substantial risk when he does so. In other words, do the best you can to find something better for yourself than what  your doctor offers. Help each other. If you discover something important, don't be afraid to share the information. Be vocal when government organizations attempt to restrict or deny your access to natural nutritional supplements. 

    If you are fortunate to find a doctor with this kind of integrity, understand the importance of what you have found and give him all of the support that you can give. There is a medical doctor in California, we will call him Doctor Q, that refused to compromise his integrity in his practice of medicine. He ended up in jail, put there by his fellow doctors. His patients got together, got him out of jail and had a special bill passed in the State legislature to protect his practice of medicine. Today he still runs a flourishing practice where he ministers to patients from all over this country. He is actually curing disease not just treating it.
 
    Third, after accepting responsibility for your own health and becoming informed, recognize that medicine is a business. Your doctor is a paid consultant just like your electrician or plumber and he is listed in the same yellow pages. You have every right to get the information for which you are paying. When your doctor retreats into arrogance and refuses to provide direct answers to direct questions, consider getting another doctor. There really are many safe and effective therapies that go far beyond drugs. However, we must demand them on the firing line, in the doctor's office, when we need them.
© 2002 Thomas Smith - All Rights Reserved 

------------------------------------------------------------------------
Thomas Smith is a reluctant medical investigator having been forced into seeking a cure for his own Diabetes because it was obvious that his doctor would not or could not cure it. He has published the results of his successful Diabetes investigation in his special report entitled "Insulin: Our Silent Killer" written for the layman but also widely valued by the  medical practitioner. This report may be purchased by sending $25.00 US to him at PO Box 7685 Loveland, Colorado 80537. He has also posted a great deal of useful information about this disease on his web page  www.Healingmatters.com He can be reached by telephone at: 1 (970) 669-9176 E-Mail: Valley@healingmatters.com
 

http://story.news.yahoo.com/news?tmpl=story&u=/ap/20030115/ap_on_he_me/surgi
cal_tools_1

Surgery Tools Left in 1,500 People a Year
Wed Jan 15, 5:09 PM ET  Add Health - AP to My Yahoo!


By JEFF DONN, Associated Press Writer

BOSTON - Surgical teams accidentally leave clamps, sponges and other tools inside about 1,500 patients nationwide each year, according to the biggest study of the problem yet. The mistakes largely result not from surgeon fatigue, but from the stress arising from emergencies or complications discovered on the operating table, the researchers reported. It also happens more often to fat patients, simply because there is more room inside them to lose equipment, according to the study.

Both the researchers and several other experts agreed that the number of such mistakes is small compared with the roughly 28 million operations a year in the United States. "But no one in any role would say it's acceptable," said Dr. Donald Berwick, president of the Boston-based nonprofit Institute for Healthcare Improvement. The study was done by researchers at Brigham and Women's Hospital and Harvard School of Public Health, both in Boston. It was published in Thursday's New England Journal of Medicine (news - web sites).

The researchers checked insurance records from about 800,000 operations in Massachusetts for 16 years ending in 2001. They counted 61 forgotten pieces of surgical equipment in 54 patients. From that, they calculated a national estimate of 1,500 cases yearly. A total of $3 million was paid out in the Massachusetts cases, mostly in settlements.
 
Two-thirds of the mistakes happened even though the equipment was counted before and after the procedure, in keeping with the standard practice. Most lost objects were sponges, but also included were metal clamps and electrodes. In two cases, 11-inch retractors — metal strips used to hold back tissue — were forgotten inside patients. In another operation, four sponges were left inside someone.

The lost objects were usually lodged around the abdomen or hips but sometimes in the chest, vagina or other cavities. They often caused tears, obstructions or infections. One patient died of complications, but the researchers withheld details for reasons of privacy.

Most patients needed additional surgery to remove the object, but sometimes it came out by itself or in a doctor's office. In other cases, patients were not even aware of the object, and it turned up in later surgery for other problems.  The study found that emergency operations are nine times more likely to lead to such mistakes, and operating-room complications requiring a change in procedure are four times more likely. A rise of one point in body-mass index, a measure of weight relative to height, raises the chances of such a mistake by 10 percent.

The length of the operation or the hour of day does not appear to make a difference, suggesting that fatigue does not cause such mistakes. "It tends to be in unpredictable situations," said lead author Dr. Atul Gawande of Brigham and Women's Hospital.  Some other researchers said fatigue could promote such mistakes in a way undetected by this study.

The Boston research team suggested that more X-ray checks be done right after those operations where such errors are most likely. Metal instruments and radiologically tagged sponges show up in such checks. Eventually, wands similar to supermarket bar-code readers might be developed to detect missing equipment, researchers said. Dr. Sidney Wolfe, health research director of the public-interest lobby group Public Citizen, said the real number of lost instruments may be even higher, because hospitals are not required to report such mistakes to public agencies. He said they should be. However, some others said such mistakes are so rare — occurring about 50 times in 1 million operations — that figuring out how to prevent them could be difficult.

"Something has to be done about this. It's just a very tough balance to decide. Do we really want to add this hoop for every patient to jump through?" said Dr. Kaveh Shojania, author of a 2001 federal study on medical mistakes. Lori Bartholomew, research director at the Physician Insurers Association of America, said: "I find it's going to be difficult to make much more improvement, because some of the risk factors are things that are hard to control." The Rockville, Md., group represents medical malpractice insurers.
 

ST. PAUL, Minn. (Jan. 18) - A hospital apologized for a laboratory mistake that resulted in the amputation of a healthy woman's breasts after she was mistakenly told she had an aggressive form of cancer.

Dr. Daniel Foley, medical director of United Hospital, told KARE-TV in the Twin Cities that the St. Paul hospital had made changes so ''this kind of mixup would never happen again.'' Linda McDougal, 46, said she was diagnosed with cancer in May 2002 after her doctor had a biopsy performed when a suspicious spot appeared on her mammogram.

McDougal said she was told the cancer was so aggressive that a double mastectomy, chemotherapy and radiation were her only chances for survival. In June, she had the surgery. Two days later, she was recovering when her doctor visited. ''She had bad news,'' McDougal said. ''She didn't know how to tell us other than to just tell us, and immediately I thought I was dying, and she told me I didn't have cancer.''

After finding no malignancy in the amputated breast tissue, McDougal said her doctor discovered a mistake in United's laboratory. Tissue from McDougal's biopsy was switched with tissue from another woman. Foley said the woman who actually had the cancer has been contacted and treated. He would not identify the pathologist at fault, but said the doctor remains with United.

''If you're right 99.9999 percent of the time, you don't want to be that .01 percent because the consequences are serious and we have to be right 100 percent of the time,'' Foley said. An attorney representing United's pathologists said the group's insurance company has paid McDougal's medical expenses and lost wages, and will continue to do so. McDougal said she is fighting several infections and must still undergo several reconstructive surgeries before she decides whether to sue for malpractice.

AP-NY-01-18-03 0432EST

Copyright 2002 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.

16 Quotes on Pharmaceutical Drugs

1. "The cause of most disease is in the poisonous drugs physicians superstitiously give in order to effect a cure." 
Charles E. Page, M.D.

2. "Medicines are of subordinate importance because of their very nature they can only work symptomatically." 
Hans Kusche, M.D.

3. "If all the medicine in the world were thrown into the sea, it would be bad for the fish and good for humanity"  
O.W. Holmes, (Prof. of Med. Harvard University)

4. "Drug medications consists in employing, as remedies for disease, those things which produce disease in well persons. Its materia medica is simply a lot of drugs or chemicals or dye-stuffs in a word poisons. All are incompatible with vital matter; all produce disease when brought in contact in any manner with the living; all are poisons." R.T. TraIl, M.D., in a two and one half hour lecture to members of congress and the medical profession, delivered at the Smithsonian Institute in Washington D.C.

5. "Every drug increases and complicates the patients condition." 
Robert Henderson, M.D.

6. "Drugs never cure disease. They merely hush the voice of nature's protest, and pull down the danger signals she erects along the pathway of transgression. Any poison taken into the system has to be reckoned with later on even though it palliates present symptoms. Pain may disappear, but the patient is left in a worse condition, though unconscious of it at the time." 
Daniel. H. Kress, M.D.

7. "The greatest part of all chronic disease is created by the suppression of acute disease by drug poisoning."   Henry Lindlahr, M.D.

8. "Every educated physician knows that most diseases are not appreciably helped by medicine." Richard C. Cabot, M.D. (Mass. Gen. Hospital)

9. "Medicine is only palliative, for back of disease lies the cause, and this cause no drug can reach." Wier Mitchel, M.D.

10. "The person who takes medicine must recover twice, once from the disease and once from the medicine."  William Osler, M.D.

11. "Medical practice has neither philosophy nor common sense to recommend it. In sickness the body is already loaded with impurities. By taking drug - medicines more impurities are added, thereby the case is further embarrassed and harder to cure." Elmer Lee, M.D., Past Vice President, Academy of Medicine.

12. "Our figures show approximately four and one half million hospital admissions annually due to the adverse reactions to drugs. Further, the average hospital patient has as much as thirty percent chance, depending how long he is in, of doubling his stay due to adverse drug reactions." 
Milton Silverman, M.D. (Professor of Pharmacology, University of California)

13. "Why would a patient swallow a poison because he is ill, or take that which would make a well man sick."   L.F. Kebler, M.D.

14. "What hope is there for medical science to ever become a true science when the entire structure of medical knowledge is built around the idea that there is an entity called disease which can be expelled when the right drug is found?" John H. Tilden, M.D.

15. "The necessity of teaching mankind not to take drugs and medicines, is a duty incumbent upon all who know their uncertainty and injurious effects; and the time is not far distant when the drug system will be abandoned."  Charles Armbruster, M. D.

16. "We are prone to thinking of drug abuse in terms of the male population and illicit drugs such as heroin, cocaine, and marijuana. It may surprise you to learn that a greater problem exists with millions of women dependent on legal prescription drugs." Robert Mendelsohn, M.D
 

 A draconian medical malpractice and medical device liability bill -  H.R. 5 - has been introduced in the House.  This bill devastates patients'  rights by capping non-economic damages, protecting makers of faulty medical  devices and shortening statutes of limitation, among other things.  There  may be congressional votes on this legislation between the end of February  and mid-March.  It is URGENT that you - and your friends, neighbors and  co-workers call your U.S. Senators and Representatives today to OPPOSE this  effort to punish patients in order to subsidize the insurance industry.  Tell your representatives that insurance companies and the drug company  lobbyist already have too much control over our healthcare system.  All  members of Congress can be reached by calling: 202-224-3121.

 The Administration's attacks on the jury system are nothing more  than a desperate attempt to change the subject away from the fact that the  insurance industry is receiving special treatment from its friends in the  Administration. President Bush and the Republican leadership in Congress  appear to be beholden to corporate special interests in Washington and are  trying to give the insurance industry and other big campaign contributors  (Remember Eli Lilly!!!!!!) more legal rights than injured patients and  American families have. Source: The Center for Responsive Politics,  President George W. Bush, Contributions by Sector, 

http://www.opensecrets.org/2000elect/sector/P00003335.htm 

 Our top priority in reforming America's health-care system should be  reducing the shameful number of preventable medical errors that kill nearly  100,000 hospital patients a year - the equivalent of three fatal plane  crashes every two days.  The day before President Bush attacked juries as  the cause of high malpractice insurance premiums for doctors, the New  England Journal of Medicine reported that surgical teams leave clamps,  sponges and other tools inside about 1,500 patients nationwide each year.  Source: AP, 1/15/03  President Bush is blaming the American jury system for rising  medical insurance rates but skyrocketing rates are a problem around the  world in countries that do not have a jury system like ours. Obstetricians  in France - which has strict limits on malpractice lawsuits and no juries -  recently threatened to walk off the job because of soaring malpractice  premiums. Source: The Guardian, 1/2/03  President Bush's "solutions" to the health-care crisis are being  driven by Washington special interests at the expense of states' rights. A  one-size-fits-all federal mandate that limits patients' rights in medical  malpractice cases would step on states' rights by wiping out existing state  laws and eliminating the authority of state Legislatures to control their  own court systems.
 

This is a message from Pedtalk - a message board for pediatricians.  This dr. won't buy thimerosal-free because of money (the date of this message is 3/5/03!!). this doctor should be in jail.
 
 "We got the same pricing.
 
 We've made the decision to only order the old-fashioned thimerasol laced  vaccine. Even at that, we will be LOSING $$ with some of the managed  care  plans.  I don't feel that we can justify the additional cost of the  thimerasol-free  vaccine. I guess if some parents insist on it, I'll give them a  script  and  have them buy it at a pharmacy."
 
 Shalom,
All the more this doc. should know better than to take the risk of using thimerosql containing vaccines.  I would suggest he attend a DAN (Defeat Autism Now) conference.  The speakers are mostly medical docs. and some have children who are on the spectrum.  The vast majority of the research done by these docs. shows that our kids have been damaged by thimerosal.

This doc. clearly needs to look at all the research that has been done.  Not only the thimerosal issue, but vaccines themselves. However, I think some docs., maybe most, are too concerned about losing their license to practice if he/she becomes involved or leaning toward the anti-vax side.

This is tragic.  I wonder if he vaccinated his grandchild?  Dr. Usman, a DAN doc., said she vaccinated her own child w/o the knowledge of thimerosal and that child is autistic (vaccine damaged).  Interesting enough, she said publicly that her last child is completely vaccine free!   I guess some docs get it and some don't.  I find it hard to believe that he could be so closed minded.  And you would think as a doc. he would understand more concerning the vaccine issue.  It sounds like it is all about $ for this fellow.

http://www.citizen.org/publications/release.cfm?ID=7232

A Free Ride for Bad Doctors (HRG Publication #1655)

This Op-Ed by Sidney Wolfe, M.D. appeared in the March 4, 2003 edition of the New York Times

A Free Ride for Bad Doctors

The death of Jésica Santillán, the 17-year-old given a heart and lung transplant last month from an incompatible donor, has become the latest argument in Congress against President Bush's plan to limit malpractice damage awards. With doctors in several states staging work stoppages to protest the soaring costs of premiums, the plan to put caps on pain-and-suffering payouts had been picking up steam.

Yet in all the discussion of tragic cases and dollar amounts, a major cause of the malpractice problem is ignored: the failure of state medical boards to discipline doctors.

The fact is, only a small percentage of doctors account for most of the money paid out in malpractice cases. From 1990 to 2002, just 5 percent of doctors were involved in 54 percent of the payouts — including jury awards and out-of-court settlements — according to the National Practitioner Data Bank of the Department of Health and Human Services. (The data bank allows hospitals and medical boards to see the records of individual doctors but, thanks to pressure from the American Medical Association, Congress forbids it to release information to doctors or the public.)

Of the 35,000 doctors with two or more payouts during that period, only 8 percent were disciplined by state medical boards. Among the 2,774 doctors who had made payments in five or more cases, only 463 — one out of six — had been disciplined.

Is it any coincidence that the states least likely to discipline doctors are among those with insurance crises? Pennsylvania — where the governor had to intervene to keep doctors from going out on strike over malpractice insurance costs — has disciplined only 5 percent of the 512 doctors who had made payments in malpractice suits five or more times, the lowest percentage of any state. (Arizona, for example, has disciplined nearly half of the doctors in this category.)

And while Pennsylvania has 5.3 percent of the doctors in the United States, they make up 18.5 percent of American doctors with five or more malpractice payments. One doctor there paid 24 claims between 1993 and 2001 totaling more than $8 million (one was for operating on the wrong part of the body; another was for leaving a "foreign body" in the patient) yet was never disciplined by Pennsylvania authorities.

The state with the next highest overrepresentation of doctors with five or more payouts is West Virginia, where doctors went on strike last month. It has 0.57 percent of the country's physicians, but they make up 1.69 percent of American doctors who have had made malpractice payments five or more times. Only one-quarter of the state's doctors with five or more payouts has been disciplined by the medical board.

In New York, another state with a pending malpractice crisis, the number of doctors who have had five or more malpractice payments is two and one-half times higher than would be expected from the number of doctors licensed. Yet only 15 percent of these 698 doctors have been disciplined by the state board.

Amid the uproar about malpractice premium increases, there is a deadly silence from physicians' groups on the crisis of inadequate doctor discipline. The problem is not the compensation paid to injured patients, but an epidemic of medical errors. If medical boards, which are state agencies, areunwilling to seriously discipline doctors who repeatedly pay for malpractice — including revoking medical licenses from the worst offenders — then legislatures must step in and change the way the boards operate.

Congress should also rethink the secrecy surrounding the practitioner data bank. While a few states release some data to the public, most Americans have no way of finding out their doctors' backgrounds. What patient would not like to discover the malpractice history of a potential doctor, especially if he is among the 2,774 in the United States who have had five or more payouts?

http://abcnews.go.com/wire/US/ap20030312_426.html
Parents of Dead Child Sue Over Transplant
Parents of Dead Child Sue Doctors, Hospitals Over Blood-Type Mistake in Liver Transplant

The Associated Press

DALLAS March 12 —
The parents of a 17-month-old girl who died last summer after receiving a transplanted liver that didn't match her blood type are suing two Dallas hospitals and three surgeons who were involved. The lawsuit alleges that doctors mistakenly gave Jeanella Aranda a liver transplant from her father instead of from her mother. The mother and child had type O blood; the father is type A.

The case recalls the death last month of Jesica Santillan, the teenager who underwent two heart-lung transplants in North Carolina. As with Jeanella, Jesica's first transplanted organs had been the wrong blood type and her body rejected them. Her parents have not said if they will sue. According to the lawsuit filed Monday in Texas, a surgeon at Children's Medical Center severed the blood veins and arteries around Jeanella's liver, causing uncontrollable bleeding. Hospital officials told the girl's parents she needed a transplant and recommended they be tested as possible donors.

A laboratory that performed the blood typing for Jeanella and her parents mixed up the blood types of the parents and incorrectly identified the father as a suitable donor of a partial liver. Partial liver donations are becoming more common because livers regenerate quickly in donor and recipient alike. The father went to Baylor University Medical Center, where surgeons removed part of his liver and sent it to Children's Medical Center. It was transplanted into Jeanella in July.

After the transplant, the girl developed a blood disorder, fever, kidney problems, lung hemorrhages and jaundice. But the blood type mismatch was not detected until 19 days after the surgery, when the mother noticed that Jeanelle's transfusions were type O, and asked whether the transplant had been a mismatch.

Doctors realized she was correct. The girl died the next day. The parents, Cesar and Alicia Aranda, are suing both hospitals and the doctors who operated on Jeanella and Cesar Aranda, claiming both hospitals should have double-checked the blood types. The physicians named in the lawsuit are Dr. Robert Goldstein, Dr. Philip Guzzetta and Dr. Jay Roden, who were involved in the operations. In statements issued Tuesday, both hospitals said they understood the father's blood type to be a match, The Dallas Morning News reported Wednesday.

"An exhaustive review of the care Jeanella received at our hospital has been conducted, and Children's believes it acted appropriately, based on the information provided to us by an external laboratory," the hospital's statement read in part

http://abcnews.go.com/wire/US/ap20030312_1745.html
Patient Dies in VA Medical Study
Patient Dies As Result of Medical Error in Veterans Affairs Medical
Study, Prompting Review

The Associated Press

WASHINGTON March 12 —
At least one patient died recently as a result of a medical error in a study at a Veterans Affairs hospital, prompting a review of the agency's entire human research effort, according to a memo released Wednesday. The memo, signed by two deputy undersecretaries for health and dated March 6, called for an intensive 90-day review at all VA medical centers of procedures used to monitor human research. Current projects will continue and patients will still be enrolled in new ones, the memo said.

The memo referred to the death "of one or more patients at one site," but did not describe the human experiments or offer any details. A House VA committee staffer said, however, the memo refers to a cancer patient who died last year during a drug trial conducted at a VA medical center in Albany, N.Y. The staffer said the death was being investigated by federal authorities, including the FBI. He said the investigation has shown that at least one researcher in the study had falsified credentials and did not hold a valid medical license.VA spokeswoman Karen Fedele said the agency would not comment further, citing an investigation by the VA's inspector general.

Dr. Jonathan B. Perlin and Laura J. Miller, the deputy undersecretaries who signed the memo, were not available for comment and a receptionist referred all questions to Louise Van Diepen, an associate in their office. She refused to discuss the memo. The Perlin-Miller memo said recent incidents in VA center human research studies "have had the potential to put research subjects at risk."

Among the incidents cited:

Falsification of individual patient data "contributed" to the death of at least one patient. Overdosing of a patient in a drug study project at another center.

An experimental procedure was conducted without the prior approval of the Institutional Review Board or the Research and Development Committee panels that have the formal responsibility of monitoring human research. A drug study was conducted without a researcher who had clinical privileges permitting the prescribing of the study medication. Failure of a review board "to meet even the minimal standards required."

Perlin and Miller ordered the 90-day review "to ensure we are doing all that is possible to ensure the protection of human subjects and the ethical conduct of research." The memo directed that directors and other officials at VA centers are to review the operations of review boards and R&D committees to  assure they are "functioning at least at the minimum level required."

The memo required that all researchers and the members of the oversight boards complete training courses on the protection of human research subjects. It also called for new procedures to assure that all researchers have the proper credentials and licenses. Finally, the memo warned that principle researchers at the VA centers "will be held responsible for ethical breaches in the conduct of their research."
 

Half of all hospital drug injections are wrong
00:01 28 March 03 NewScientist.com news service
Half of all drug injections given intravenously in hospitals are done wrongly, a new study reveals, with third of these being potentially dangerous.

British researchers uncovered the disturbing level of errors when they examined drugs given intravenously by nurses in two hospitals in the UK. They believe the rate of mistakes they found is likely to be representative of practice across Europe and the US.

Nick Barber and Katja Taxis, at the School of Pharmacy, London, tracked the preparation and administration of over 400 intravenous (IV) doses given to patients on 10 different wards in the hospitals. "We were surprised about how commonly errors occurred," say Barber. "But not all of these were serious."

However, the error rate they calculated from their data predicts one serious error every day in every hospital in the UK, which is a concern, he says. The most common mistakes were injecting doses of concentrated drugs too rapidly and preparing drugs incorrectly, by either using the wrong dose or dissolving them in the wrong solution. All could be fatal in certain circumstances.

Speed kills

For some drugs, the speed at which it enters the body is crucial, Barber explains. If they are injected too fast, they can induce anaphylaxis - a life-threatening allergic reaction. "This is because there is a load of potent foreign chemical shooting around your body - if it hits the brain or heart it can have a marked effect," he said. But injecting a drug slowly, for example, over three minutes can be physically difficult for health care staff.

One of the three "potentially severe" errors Barber and Taxis in their study was of this type - with the antibiotic vancomycin being given too quickly. However, a pharmacist observer for the study intervened before any harm was done.
 
Nick Barber, School of Pharmacy, London  National Patient Safety Agency, UK  British Medical Journal The second severe error occurred when a patient was nearly injected with an IV preparation containing five times the correct dose of heparin - which stops the blood clotting. "Wrong dose errors are the ones most likely to cause harm," notes Barber. The third potentially lethal error was when an intensive care team infusing a patient with adrenalin ran out of the drug and had not prepared a second infusion in time. Barber says the key to tackling such errors was to improve nurse training. He says there would also be a role for companies to develop a simple pump to help nurses administer drugs slowly.

Journal reference: British Medical Journal (vol 326, p 684)
 

http://www.chicagotribune.com/news/printedition/chi-0303120217mar12,1,5409512.story?coll=chi%2Dprintnews%2Dhed

Schools shift rules on pelvic procedure
Exams often done without consent


By David B. Caruso
Associated Press
Published March 12, 2003

PHILADELPHIA -- Some of the nation's leading medical schools have abandoned a little-known, decades-old practice of letting students perform pelvic exams on women without their consent while they are under anesthesia.

The institutions that have recently implemented policies of asking for permission routinely brought in students--sometimes as many as three or four--to conduct pelvic exams on unconscious women just before their gynecological surgeries, often without their consent. Changes in that practice have taken place over the past five years after complaints from students who felt the exams without consent were unethical. "My problem was that if they found out about it, they might be really upset, and it was really only being done for my benefit," said Dr. Ari Silver-Isenstadt, who refused to examine anesthetized women as a student at
the University of Pennsylvania.

Students also raised objections in the mid-1990s at Harvard Medical School.Dr. Daniel Federman, senior dean for clinical teaching at Harvard, said the complaints led to a new policy under which surgical patients had to give consent for a pelvic exam for training purposes. In addition, the students had to be part of the medical team. "Very few patients decline," Federman said. "And when they do, we honor it." At the University of California-San Francisco, complaints by medical students in the late 1990s led to a line being added to patient consent forms, specifically noting that women having gynecological surgery may be  given a pelvic exam while they are under anesthesia.

Typically, the surgeon performing the operation conducts an exam to confirm the problem to be corrected by surgery. Dr. Patricia Robertson, director of UCSF's obstetrics and gynecology clerkship, said students also have been directed to meet the patient before each operation and explain how they will be involved in their care. "The students, I think, were most upset because they felt there were  students lining up in the operating room doing pelvic exams who really had nothing to do with the patient," she said.

Most medical students today learn basics of the pelvic exam by practicing on paid volunteers. Anesthetized women are the perfect subjects, doctors said, because they are unable to feel the sometimes painful mistakes of novice examiners. Consent is still far from a universal practice. At the Washington University School of Medicine in St. Louis, for instance, patients are told that students will be part of their care team, but aren't specifically told the treatment could include a pelvic exam for educational  purposes.

"I don't think any of us even think about it," said Dr. Jessica Bienstock, residency program director at Johns Hopkins University. "It's just so standard as to how you train medical students." Many students, however, appear to disagree: 70 percent surveyed at Philadelphia-area hospitals in 1995 before they completed an obstetrics and gynecology clerkship said it was important to ask women for consent, according to a study published last month in the American Journal of Obstetrics and Gynecology.

Dr. Michael Gregory, a Boston public health physician who objected to the exams when he was a third-year student at Tufts University School of Medicine, said that while studies show most women will give their consent, doctors are afraid to ask. "It's this paternalistic, patronizing view that the doctors know best. ... We underestimate people's incredible charity, and their willingness to let us train," he said. "But I think that at a gut level, doctors understand that if they actually told patients that this was happening without their consent, people would be outraged."
 

http://grants1.nih.gov/grants/guide/rfa-files/RFA-HS-03-005.html

Patient safety is a top priority in the Nation today. The Institute of Medicine (IOM) report entitled "To Err is Human", (in ref. 9) estimated that between 44,000 and 98,000 people die each year in hospitals from medical errors. The majority of these errors are a result of systemic problems  rather than poor performance by individual providers. Although, the United States provides some of the best health care in the world, the number of patients that are being harmed as a result of the process of health care is  unacceptably high. In response to the IOM report, the Quality Interagency Coordination Task Force (QuIC), which is composed of Federal members representing the Departments of Health and Human Services (DHHS), Labor (DoL), Defense (DoD), Veterans Affairs (VA), and Commerce; Office of Management and Budget (OMB); Office of Personnel Management (OPM); U.S. Coast Guard, Federal Bureau of Prisons (BoP); National Highway Transportation and Safety Administration; and the Federal Trade Commission (FTC), issued a report in February 2000 "Doing What Counts for Patient Safety, Federal Action to Reduce Medical Errors and Their Impact". (See ref. 10)

http://curezone.com/forums/m.asp?f=214&i=25

The Soft Science of Dietary Fat by Gary Taubes Science magazine Mainstream nutritional science has demonized dietary fat, yet 50 years and hundreds of millions of dollars of research have failed to prove that eating a low-fat diet will help you live longer When the U.S. Surgeon General's Office set off in 1988 to write the definitive report on the dangers of dietary fat, the scientific task appeared straightforward. Four years earlier, the National Institutes of Health (NIH) had begun advising every American old enough to walk to restrict fat intake, and the president of the American Heart Association (AHA) had told Time magazine that if everyone went along, "we will have [atherosclerosis] conquered" by the year 2000. The Surgeon General's Office itself had just published its 700-page landmark "Report on Nutrition and Health," declaring fat the single most unwholesome component of the American diet.

All of this was apparently based on sound science. So the task before the project officer was merely to gather that science together in one volume, have it reviewed by a committee of experts, which had been promptly established, and publish it. The project did not go smoothly, however. Four project officers came and went over the next decade. "It consumed project officers," says Marion Nestle, who helped launch the project and now runs the nutrition and food studies department at New York University (NYU). Members of the oversight committee saw drafts of an early chapter or two, criticized them vigorously, and then saw little else.

Finally, in June 1999, 11 years after the project began, the Surgeon General's Office circulated a letter, authored by the last of the project officers, explaining that the report would be killed. There was no other public announcement and no press release. The letter explained that the relevant administrators "did not anticipate fully the magnitude of the additional external expertise and staff resources that would be needed." In other words, says Nestle, the subject matter "was too complicated." Bill Harlan, a member of the oversight committee and associate director of the Office of Disease Prevention at NIH, says "the report was initiated with a preconceived opinion of the conclusions," but the science behind those opinions was not holding up. "Clearly the thoughts of yesterday were not going to serve us very well."

During the past 30 years, the concept of eating healthy in America has become synonymous with avoiding dietary fat. The creation and marketing of reduced-fat food products has become big business; over 15,000 have appeared on supermarket shelves. Indeed, an entire research industry has arisen to create palatable nonfat fat substitutes, and the food industry now spends billions of dollars yearly selling the less-fat-is-good-health message. The government weighs in as well, with the U.S. Department of Agriculture's (USDA's) booklet on dietary guidelines, published every 5 years, and its ubiquitous Food Guide Pyramid, which recommends that fats and oils be eaten "sparingly." The low-fat gospel spreads farther by a kind of societal osmosis, continuously reinforced by physicians, nutritionists, journalists, health organizations, and consumer advocacy groups such as the Center for Science in the Public Interest, which refers to fat as this "greasy killer." "In America, we no longer fear God or the communists, but we fear fat," says David Kritchevsky of the Wistar Institute in Philadelphia, who in 1958 wrote the first textbook on cholesterol.

As the Surgeon General's Office discovered, however, the science of dietary fat is not nearly as simple as it once appeared. The proposition, now 50 years old, that dietary fat is a bane to health is based chiefly on the fact that fat, specifically the hard, saturated fat found primarily in meat and dairy products, elevates blood cholesterol levels. This in turn raises the likelihood that cholesterol will clog arteries, a condition known as atherosclerosis, which then increases risk of coronary artery disease, heart attack, and untimely death. By the 1970s, each individual step of this chain from fat to cholesterol to heart disease had been demonstrated beyond reasonable doubt, but the veracity of the chain as a whole has never been proven. In other words, despite decades of research, it is still a debatable proposition whether the consumption of saturated fats above recommended levels (step one in the chain) by anyone who's not already at high risk of heart disease will increase the likelihood of untimely death (outcome three). Nor have hundreds of millions of dollars in trials managed to generate compelling evidence that healthy individuals can extend their lives by more than a few weeks, if that, by eating less fat (see sidebar on p. 2538). To put it simply, the data remain ambiguous as to whether low-fat diets will benefit healthy Americans. Worse, the ubiquitous admonishments to reduce total fat intake have encouraged a shift to high-carbohydrate diets, which may be no better--and may even be worse--than high-fat diets.

Since the early 1970s, for instance, Americans' average fat intake has dropped from over 40% of total calories to 34%; average serum cholesterol levels have dropped as well. But no compelling evidence suggests that these decreases have improved health. Although heart disease death rates have dropped--and public health officials insist low-fat diets are partly responsible--the incidence of heart disease does not seem to be declining, as would be expected if lower fat diets made a difference. This was the conclusion, for instance, of a 10-year study of heart disease mortality published in The New England Journal of Medicine in 1998, which suggested that death rates are declining largely because doctors are treating the disease more successfully. AHA statistics agree: Between 1979 and 1996, the number of medical procedures for heart disease increased from 1.2 million to 5.4 million a year. "I don't consider that this disease category has disappeared or anything close to it," says one AHA statistician.

Meanwhile, obesity in America, which remained constant from the early 1960s through 1980, has surged upward since then--from 14% of the population to over 22%. Diabetes has increased apace. Both obesity and diabetes increase heart disease risk, which could explain why heart disease incidence is not decreasing. That this obesity epidemic occurred just as the government began bombarding Americans with the low-fat message suggests the possibility, however distant, that low-fat diets might have unintended consequences--among them, weight gain. "Most of us would have predicted that if we can get the population to change its fat intake, with its dense calories, we would see a reduction in weight," admits Harlan. "Instead, we see the exact opposite."

In the face of this uncertainty, skeptics and apostates have come along repeatedly, only to see their work almost religiously ignored as the mainstream medical community sought consensus on the evils of dietary fat. For 20 years, for instance, the Harvard School of Public Health has run the Nurses' Health Study and its two sequelae--the Health Professionals Follow-Up Study and the Nurses' Health Study II--accumulating over a decade of data on the diet and health of almost 300,000 Americans. The results suggest that total fat consumed has no relation to heart disease risk; that monounsaturated fats like olive oil lower risk; and that saturated fats are little worse, if at all, than the pasta and other carbohydrates that the Food Guide Pyramid suggests be eaten copiously. (The studies also suggest that trans fatty acids are unhealthful. These are the fats in margarine, for instance, and are what many Americans started eating when they were told that the saturated fats in butter might kill them.) Harvard epidemiologist Walter Willett, spokesperson for the Nurses' Health Study, points out that NIH has spent over $100 million on the three studies and yet not one government agency has changed its primary guidelines to fit these particular data. "Scandalous," says Willett. "They say, 'You really need a high level of proof to change the recommendations,' which is ironic, because they never had a high level of proof to set them."

Indeed, the history of the national conviction that dietary fat is deadly, and its evolution from hypothesis to dogma, is one in which politicians, bureaucrats, the media, and the public have played as large a role as the scientists and the science. It's a story of what can happen when the demands of public health policy--and the demands of the public for simple advice--run up against the confusing ambiguity of real science.

Fear of fat During the first half of the 20th century, nutritionists were more concerned about malnutrition than about the sins of dietary excess. After World War II, however, a coronary heart disease epidemic seemed to sweep the country (see sidebar on p. 2540). "Middle-aged men, seemingly healthy, were dropping dead," wrote biochemist Ancel Keys of the University of Minnesota, Twin Cities, who was among the first to suggest that dietary fats might be the cause. By 1952, Keys was arguing that Americans should reduce their fat intake to less than 30% of total calories, although he simultaneously recognized that "direct evidence on the effect of the diet on human arteriosclerosis is very little and likely to remain so for some time." In the famous and very controversial Seven Countries Study, for instance, Keys and his colleagues reported that the amount of fat consumed seemed to be the salient difference between populations such as those in Japan and Crete that had little heart disease and those, as in Finland, that were plagued by it. In 1961, the Framingham Heart Study linked cholesterol levels to heart disease, Keys made the cover of Time magazine, and the AHA, under his influence, began advocating low-fat diets as a palliative for men with high cholesterol levels. Keys had also become one of the first Americans to consciously adopt a heart-healthy diet: He and his wife, Time reported, "do not eat 'carving meat'--steaks, chops, roasts--more than three times a week."

Nonetheless, by 1969 the state of the science could still be summarized by a single sentence from a report of the Diet-Heart Review Panel of the National Heart Institute (now the National Heart, Lung, and Blood Institute, or NHLBI): "It is not known whether dietary manipulation has any effect whatsoever on coronary heart disease." The chair of the panel was E. H. "Pete" Ahrens, whose laboratory at Rockefeller University in New York City did much of the seminal research on fat and cholesterol metabolism.

Whereas proponents of low-fat diets were concerned primarily about the effects of dietary fat on cholesterol levels and heart disease, Ahrens and his panel--10 experts in clinical medicine, epidemiology, biostatistics, human nutrition, and metabolism--were equally concerned that eating less fat could have profound effects throughout the body, many of which could be harmful. The brain, for instance, is 70% fat, which chiefly serves to insulate neurons. Fat is also the primary component of cell membranes. Changing the proportion of saturated to unsaturated fats in the diet changes the fat composition in these membranes. This could conceivably change the membrane permeability, which controls the transport of everything from glucose, signaling proteins, and hormones to bacteria, viruses, and tumor-causing agents into and out of the cell. The relative saturation of fats in the diet could also influence cellular aging as well as the clotting ability of blood cells.

Whether the potential benefits of low-fat diets would exceed the potential risks could be settled by testing whether low-fat diets actually prolong life, but such a test would have to be enormous. The effect of diet on cholesterol levels is subtle for most individuals--especially those living in the real world rather than the metabolic wards of nutrition researchers--and the effect of cholesterol levels on heart disease is also subtle. As a result, tens of thousands of individuals would have to switch to low-fat diets and their subsequent health compared to that of equal numbers who continued eating fat to alleged excess. And all these people would have to be followed for years until enough deaths accumulated to provide statistically significant results. Ahrens and his colleagues were pessimistic about whether such a massive and expensive trial could ever be done. In 1971, an NIH task force estimated such a trial would cost $1 billion, considerably more than NIH was willing to spend. Instead, NIH administrators opted for a handful of smaller studies, two of which alone would cost $255 million. Perhaps more important, these studies would take a decade. Neither the public, the press, nor the U.S. Congress was willing to wait that long.

Science by committee Like the flourishing American affinity for alternative medicine, an antifat movement evolved independently of science in the 1960s. It was fed by distrust of the establishment--in this case, both the medical establishment and the food industry--and by counterculture attacks on excessive consumption, whether manifested in gas-guzzling cars or the classic American cuisine of bacon and eggs and marbled steaks. And while the data on fat and health remained ambiguous and the scientific community polarized, the deadlock was broken not by any new science, but by politicians. It was Senator George McGovern's bipartisan, nonlegislative Select Committee on Nutrition and Human Needs--and, to be precise, a handful of McGovern's staff members--that almost single-handedly changed nutritional policy in this country and initiated the process of turning the dietary fat hypothesis into dogma.

McGovern's committee was founded in 1968 with a mandate to eradicate malnutrition in America, and it instituted a series of landmark federal food assistance programs. As the malnutrition work began to peter out in the mid-1970s, however, the committee didn't disband. Rather, its general counsel, Marshall Matz, and staff director, Alan Stone, both young lawyers, decided that the committee would address "overnutrition," the dietary excesses of Americans. It was a "casual endeavor," says Matz. "We really were totally naïve, a bunch of kids, who just thought, 'Hell, we should say something on this subject before we go out of business.' " McGovern and his fellow senators--all middle-aged men worried about their girth and their health--signed on; McGovern and his wife had both gone through diet-guru Nathan Pritikin's very low fat diet and exercise program. McGovern quit the program early, but Pritikin remained a major influence on his thinking.

McGovern's committee listened to 2 days of testimony on diet and disease in July 1976. Then resident wordsmith Nick Mottern, a former labor reporter for The Providence Journal, was assigned the task of researching and writing the first "Dietary Goals for the United States." Mottern, who had no scientific background and no experience writing about science, nutrition, or health, believed his Dietary Goals would launch a "revolution in diet and agriculture in this country." He avoided the scientific and medical controversy by relying almost exclusively on Harvard School of Public Health nutritionist Mark Hegsted for input on dietary fat. Hegsted had studied fat and cholesterol metabolism in the early 1960s, and he believed unconditionally in the benefits of restricting fat intake, although he says he was aware that his was an extreme opinion. With Hegsted as his muse, Mottern saw dietary fat as the nutritional equivalent of cigarettes, and the food industry as akin to the tobacco industry in its willingness to suppress scientific truth in the interests of profits. To Mottern, those scientists who spoke out against fat were those willing to take on the industry. "It took a certain amount of guts," he says, "to speak about this because of the financial interests involved."

Mottern's report suggested that Americans cut their total fat intake to 30% of the calories they consume and saturated fat intake to 10%, in accord with AHA recommendations for men at high risk of heart disease. The report acknowledged the existence of controversy but insisted Americans had nothing to lose by following its advice. "The question to be asked is not why should we change our diet but why not?" wrote Hegsted in the introduction. "There are [no risks] that can be identified and important benefits can be expected." This was an optimistic but still debatable position, and when Dietary Goals was released in January 1977, "all hell broke loose," recalls Hegsted. "Practically nobody was in favor of the McGovern recommendations. Damn few people."

McGovern responded with three follow-up hearings, which aptly foreshadowed the next 7 years of controversy. Among those testifying, for instance, was NHLBI director Robert Levy, who explained that no one knew if eating less fat or lowering blood cholesterol levels would prevent heart attacks, which was why NHLBI was spending $300 million to study the question. Levy's position was awkward, he recalls, because "the good senators came out with the guidelines and then called us in to get advice." He was joined by prominent scientists, including Ahrens, who testified that advising Americans to eat less fat on the strength of such marginal evidence was equivalent to conducting a nutritional experiment with the American public as subjects. Even the American Medical Association protested, suggesting that the diet proposed by the guidelines raised the "potential for harmful effects." But as these scientists testified, so did representatives from the dairy, egg, and cattle industries, who also vigorously opposed the guidelines for obvious reasons.
This juxtaposition served to taint the scientific criticisms: Any scientists arguing against the committee's guidelines appeared to be either hopelessly behind the paradigm, which was Hegsted's view, or industry apologists, which was Mottern's, if not both.

Although the committee published a revised edition of the Dietary Goals later in the year, the thrust of the recommendations remained unchanged. It did give in to industry pressure by softening the suggestion that Americans eat less meat. Mottern says he considered even that a "disservice to the public," refused to do the revisions, and quit the committee. (Mottern became a vegetarian while writing the Dietary Goals and now runs a food co-op in Peekskill, New York.)

The guidelines might have then died a quiet death when McGovern's committee came to an end in late 1977 if two federal agencies had not felt it imperative to respond. Although they took contradictory points of view, one message--with media assistance--won out.

The first was the USDA, where consumer-activist Carol Tucker Foreman had recently been appointed an assistant secretary. Foreman believed it was incumbent on USDA to turn McGovern's recommendations into official policy, and, like Mottern, she was not deterred by the existence of scientific controversy. "Tell us what you know and tell us it's not the final answer," she would tell scientists. "I have to eat and feed my children three times a day, and I want you to tell me what your best sense of the data is right now."

Of course, given the controversy, the "best sense of the data" would depend on which scientists were asked. The Food and Nutrition Board of the National Academy of Sciences (NAS), which decides the Recommended Dietary Allowances, would have been a natural choice, but NAS president Philip Handler, an expert on metabolism, had told Foreman that Mottern's Dietary Goals were "nonsense." Foreman then turned to McGovern's staffers for advice and they recommended she hire Hegsted, which she did. Hegsted, in turn, relied on a state-of-the-science report published by an expert but very divergent committee of the American Society for Clinical Nutrition. "They were nowhere near unanimous on anything," says Hegsted, "but the majority supported something like the McGovern committee report."

The resulting document became the first edition of "Using the Dietary Guidelines for Americans." Although it acknowledged the existence of controversy and suggested that a single dietary recommendation might not suit an entire diverse population, the advice to avoid fat and saturated fat was, indeed, virtually identical to McGovern's Dietary Goals.

Three months later, the NAS Food and Nutrition Board released its own guidelines: "Toward Healthful Diets." The board, consisting of a dozen nutrition experts, concluded that the only reliable advice for healthy Americans was to watch their weight; everything else, dietary fat included, would take care of itself. The advice was not taken kindly, however, at least not by the media. The first reports--"rather incredulously," said Handler at the time--criticized the NAS advice for conflicting with the USDA's and McGovern's and thus somehow being irresponsible. Follow-up reports suggested that the board members, in the words of Jane Brody, who covered the story for The New York Times, were "all in the pocket of the industries being hurt." To be precise, the board chair and one of its members consulted for food industries, and funding for the board itself came from industry donations. These industry connections were leaked to the press from the USDA.

Hegsted now defends the NAS board, although he didn't at the time, and calls this kind of conflict of interest "a hell of an issue." "Everybody used to complain that industry didn't do anything on nutrition," he told Science, "yet anybody who got involved was blackballed because their positions were presumably influenced by the industry." (In 1981, Hegsted returned to Harvard, where his research was funded by Frito-Lay.) The press had mixed feelings, claiming that the connections "soiled" the academy's reputation "for tendering careful scientific advice" (The Washington Post), demonstrated that the board's "objectivity and aptitude are in doubt" (The New York Times), or represented in the board's guidelines a "blow against the food faddists who hold the public in thrall" (Science). In any case, the NAS board had been publicly discredited. Hegsted's Dietary Guidelines for Americans became the official U.S. policy on dietary fat: Eat less fat. Live longer.

Creating "consensus"
Once politicians, the press, and the public had decided dietary fat policy, the science was left to catch up. In the early 1970s, when NIH opted to forgo a $1 billion trial that might be definitive and instead fund a half-dozen studies at one-third the cost, everyone hoped these smaller trials would be sufficiently persuasive to conclude that low-fat diets prolong lives. The results were published between 1980 and 1984. Four of these trials --comparing heart disease rates and diet within Honolulu, Puerto Rico, Chicago, and Framingham--showed no evidence that men who ate less fat lived longer or had fewer heart attacks. A fifth trial, the Multiple Risk Factor Intervention Trial (MRFIT), cost $115 million and tried to amplify the subtle influences of diet on health by persuading subjects to avoid fat while simultaneously quitting smoking and taking medication for high blood pressure. That trial suggested, if anything, that eating less fat might shorten life. In each study, however, the investigators concluded that methodological flaws had led to the negative results. They did not, at least publicly, consider their results reason to lessen their belief in the evils of fat.

The sixth study was the $140 million Lipid Research Clinics (LRC) Coronary Primary Prevention Trial, led by NHLBI administrator Basil Rifkind and biochemist Daniel Steinberg of the University of California, San Diego. The LRC trial was a drug trial, not a diet trial, but the NHLBI heralded its outcome as the end of the dietary fat debate. In January 1984, LRC investigators reported that a medication called cholestyramine reduced cholesterol levels in men with abnormally high cholesterol levels and modestly reduced heart disease rates in the process. (The probability of suffering a heart attack during the seven-plus years of the study was reduced from 8.6% in the placebo group to 7.0%; the probability of dying from a heart attack dropped from 2.0% to 1.6%.) The investigators then concluded, without benefit of dietary data, that cholestyramine's benefits could be extended to diet as well. And although the trial tested only middle-aged men with cholesterol levels higher than those of 95% of the population, they concluded that those benefits "could and should be extended to other age groups and women and ... other more modest elevations of cholesterol levels."

Why go so far? Rifkind says their logic was simple: For 20 years, he and his colleagues had argued that lowering cholesterol levels prevented heart attacks. They had spent enormous sums trying to prove it. They felt they could never actually demonstrate that low-fat diets prolonged lives--that would be too expensive, and MRFIT had failed--but now they had established a fundamental link in the causal chain, from lower cholesterol levels to cardiovascular health. With that, they could take the leap of faith from cholesterol-lowering drugs and health to cholesterol-lowering diet and health. And after all their effort, they were eager--not to mention urged by Congress--to render helpful advice. "There comes a point when, if you don't make a decision, the consequences can be great as well," says Rifkind. "If you just allow Americans to keep on consuming 40% of calories from fat, there's an outcome to that as well."

With the LRC results in press, the NHLBI launched what Levy called "a massive public health campaign." The media obligingly went along. Time, for instance, reported the LRC findings under the headline "Sorry, It's True. Cholesterol really is a killer." The article about a drug trial began: "No whole milk. No butter. No fatty meats ..." Time followed up 3 months later with a cover story: "And Cholesterol and Now the Bad News. ..." The cover photo was a frowning face: a breakfast plate with two fried eggs as the eyes and a bacon strip for the mouth. Rifkind was quoted saying that their results "strongly indicate that the more you lower cholesterol and fat in your diet, the more you reduce your risk of heart disease," a statement that still lacked direct scientific support.

The following December, NIH effectively ended the debate with a "Consensus Conference." The idea of such a conference is that an expert panel, ideally unbiased, listens to 2 days of testimony and arrives at a conclusion with which everyone agrees. In this case, Rifkind chaired the planning committee, which chose his LRC co-investigator Steinberg to lead the expert panel. The 20 speakers did include a handful of skeptics --including Ahrens, for instance, and cardiologist Michael Oliver of Imperial College in London--who argued that it was unscientific to equate the effects of a drug with the effects of a diet. Steinberg's panel members, however, as Oliver later complained in The Lancet, "were selected to include only experts who would, predictably, say that all levels of blood cholesterol in the United States are too high and should be lowered.

And, of course, this is exactly what was said." Indeed, the conference report, written by Steinberg and his panel, revealed no evidence of discord. There was "no doubt," it concluded, that low-fat diets "will afford significant protection against coronary heart disease" to every American over 2 years old. The Consensus Conference officially gave the appearance of unanimity where none existed. After all, if there had been a true consensus, as Steinberg himself told Science, "you wouldn't have had to have a consensus conference."

The test of time To the outside observer, the challenge in making sense of any such long-running scientific controversy is to establish whether the skeptics are simply on the wrong side of the new paradigm, or whether their skepticism is well founded. In other words, is the science at issue based on sound scientific thinking and unambiguous data, or is it what Sir Francis Bacon, for instance, would have called "wishful science," based on fancies, opinions, and the exclusion of contrary evidence? Bacon offered one viable suggestion for differentiating the two: the test of time. Good science is rooted in reality, so it grows and develops and the evidence gets increasingly more compelling, whereas wishful science flourishes most under its first authors before "going downhill."

Such is the case, for instance, with the proposition that dietary fat causes cancer, which was an integral part of dietary fat anxiety in the late 1970s. By 1982, the evidence supporting this idea was thought to be so undeniable that a landmark NAS report on nutrition and cancer equated those researchers who remained skeptical with "certain interested parties [who] formerly argued that the association between lung cancer and smoking was not causational." Fifteen years and hundreds of millions of research dollars later, a similarly massive expert report by the World Cancer Research Fund and the American Institute for Cancer Research could find neither "convincing" nor even "probable" reason to believe that dietary fat caused cancer.

The hypothesis that low-fat diets are the requisite route to weight loss has taken a similar downward path. This was the ultimate fallback position in all low-fat recommendations: Fat has nine calories per gram compared to four calories for carbohydrates and protein, and so cutting fat from the diet surely would cut pounds. "This is held almost to be a religious truth," says Harvard's Willett. Considerable data, however, now suggest otherwise. The results of well-controlled clinical trials are consistent: People on low-fat diets initially lose a couple of kilograms, as they would on any diet, and then the weight tends to return. After 1 to 2 years, little has been achieved. Consider, for instance, the 50,000 women enrolled in the ongoing $100 million Women's Health Initiative (WHI). Half of these women have been extensively counseled to consume only 20% of their calories from fat. After 3 years on this near-draconian regime, say WHI sources, the women had lost, on average, a kilogram each.

The link between dietary fat and heart disease is more complicated, because the hypothesis has diverged into two distinct propositions: first, that lowering cholesterol prevents heart disease; second, that eating less fat not only lowers cholesterol and prevents heart disease but prolongs life. Since 1984, the evidence that cholesterol-lowering drugs are beneficial--proposition number one--has indeed blossomed, at least for those at high risk of heart attack. These drugs reduce serum cholesterol levels dramatically, and they prevent heart attacks, perhaps by other means as well. Their market has now reached $4 billion a year in the United States alone, and every new trial seems to confirm their benefits.

The evidence supporting the second proposition, that eating less fat makes for a healthier and longer life, however, has remained stubbornly ambiguous. If anything, it has only become less compelling over time. Indeed, since Ancel Keys started advocating low-fat diets almost 50 years ago, the science of fat and cholesterol has evolved from a simple story into a very complicated one. The catch has been that few involved in this business were prepared to deal with a complicated story. Researchers initially preferred to believe it was simple--that a single unwholesome nutrient, in effect, could be isolated from the diverse richness of human diets; public health administrators required a simple story to give to Congress and the public; and the press needed a simple story--at least on any particular day--to give to editors and readers in 30 column inches. But as contrarian data continued to accumulate, the complications became increasingly more difficult to ignore or exclude, and the press began waffling or adding caveats. The scientists then got the blame for not sticking to the original simple story, which had, regrettably, never existed.

More fats, fewer answers The original simple story in the 1950s was that high cholesterol levels increase heart disease risk. The seminal Framingham Heart Study, for instance, which revealed the association between cholesterol and heart disease, originally measured only total serum cholesterol. But cholesterol shuttles through the blood in an array of packages. Low-density lipoprotein particles (LDL, the "bad" cholesterol) deliver fat and cholesterol from the liver to tissues that need it, including the arterial cells, where it can lead to atherosclerotic plaques. High-density lipoproteins (HDLs, the "good" cholesterol) return cholesterol to the liver. The higher the HDL, the lower the heart disease risk. Then there are triglycerides, which contain fatty acids, and very low density lipoproteins (VLDLs), which transport triglycerides.

All of these particles have some effect on heart disease risk, while the fats, carbohydrates, and protein in the diet have varying effects on all these particles. The 1950s story was that saturated fats increase total cholesterol, polyunsaturated fats decrease it, and monounsaturated fats are neutral. By the late 1970s--when researchers accepted the benefits of HDL--they realized that monounsaturated fats are not neutral. Rather, they raise HDL, at least compared to carbohydrates, and lower LDL. This makes them an ideal nutrient as far as cholesterol goes. Furthermore, saturated fats cannot be quite so evil because, while they elevate LDL, which is bad, they also elevate HDL, which is good. And some saturated fats--stearic acid, in particular, the fat in chocolate--are at worst neutral. Stearic acid raises HDL levels but does little or nothing to LDL. And then there are trans fatty acids, which raise LDL, just like saturated fat, but also lower HDL. Today, none of this is controversial, although it has yet to be reflected in any Food Guide Pyramid.

To understand where this complexity can lead in a simple example, consider a steak--to be precise, a porterhouse, select cut, with a half-centimeter layer of fat, the nutritional constituents of which can be found in the Nutrient Database for Standard Reference at the USDA Web site. After broiling, this porterhouse reduces to a serving of almost equal parts fat and protein. Fifty-one percent of the fat is monounsaturated, of which virtually all (90%) is oleic acid, the same healthy fat that's in olive oil. Saturated fat constitutes 45% of the total fat, but a third of that is stearic acid, which is, at the very least, harmless. The remaining 4% of the fat is polyunsaturated, which also improves cholesterol levels. In sum, well over half--and perhaps as much as 70%--of the fat content of a porterhouse will improve cholesterol levels compared to what they would be if bread, potatoes, or pasta were consumed instead. The remaining 30% will raise LDL but will also raise HDL. All of this suggests that eating a porterhouse steak rather than carbohydrates might actually improve heart disease risk, although no nutritional authority who hasn't written a high-fat diet book will say this publicly.

As for the scientific studies, in the years since the 1984 consensus conference, the one thing they have not done is pile up evidence in support of the low-fat-for-all approach to the public good. If anything, they have added weight to Ahrens's fears that there may be a downside to populationwide low-fat recommendations. In 1986, for instance, just 1 year after NIH launched the National Cholesterol Education Program, also advising low-fat diets for everyone over 2 years old, epidemiologist David Jacobs of the University of Minnesota, Twin Cities, visited Japan. There he learned that Japanese physicians were advising patients to raise their cholesterol levels, because low cholesterol levels were linked to hemorrhagic stroke. At the time, Japanese men were dying from stroke almost as frequently as American men were succumbing to heart disease. Back in Minnesota, Jacobs looked for this low-cholesterol-stroke relationship in the MRFIT data and found it there, too. And the relationship transcended stroke: Men with very low cholesterol levels seemed prone to premature death; below 160 milligrams per deciliter (mg/dl), the lower the cholesterol level, the shorter the life.

Jacobs reported his results to NHLBI, which in 1990 hosted a conference to discuss the issue, bringing together researchers from 19 studies around the world. The data were consistent: When investigators tracked all deaths, instead of just heart disease deaths, the cholesterol curves were U-shaped for men and flat for women. In other words, men with cholesterol levels above 240 mg/dl tended to die prematurely from heart disease. But below 160 mg/dl, the men tended to die prematurely from cancer, respiratory and digestive diseases, and trauma. As for women, if anything, the higher their cholesterol, the longer they lived (see graph on p. 2540).

These mortality data can be interpreted in two ways. One, preferred by low-fat advocates, is that they cannot be meaningful. Rifkind, for instance, told Science that the excess deaths at low cholesterol levels must be due to preexisting conditions. In other words, chronic illness leads to low cholesterol levels, not vice versa. He pointed to the 1990 conference report as the definitive document on the issue and as support for his argument, although the report states unequivocally that this interpretation is not supported by the data.

The other interpretation is that what a low-fat diet does to serum cholesterol levels, and what that in turn does to arteries, may be only one component of the diet's effect on health. In other words, while low-fat diets might help prevent heart disease, they might also raise susceptibility to other conditions. This is what always worried Ahrens. It's also one reason why the American College of Physicians, for instance, now suggests that cholesterol reduction is certainly worthwhile for those at high, short-term risk of dying of coronary heart disease but of "much smaller or ... uncertain" benefit for everyone else.

This interpretation--that the connection between diet and health far transcends cholesterol--is also supported by the single most dramatic diet-heart trial ever conducted: the Lyon Diet Heart Study, led by Michel de Lorgeril of the French National Institute of Health and Medical Research (INSERM) and published in Circulation in February 1999. The investigators randomized 605 heart attack survivors, all on cholesterol-lowering drugs, into two groups. They counseled one to eat an AHA "prudent diet," very similar to that recommended for all Americans. They counseled the other to eat a Mediterranean-type diet, with more bread, cereals, legumes, beans, vegetables, fruits, and fish and less meat. Total fat and types of fat differed markedly in the two diets, but the HDL, LDL, and total cholesterol levels in the two groups remained virtually identical. Nonetheless, over 4 years of follow-up, the Mediterranean-diet group had only 14 cardiac deaths and nonfatal heart attacks compared to 44 for the "Western-type" diet group. The likely explanation, wrote de Lorgeril and his colleagues, is that the "protective effects [of the Mediterranean diet] were not related to serum concentrations of total, LDL or HDL cholesterol."

Many researchers find the Lyon data so perplexing that they're left questioning the methodology of the trial. Nonetheless, says NIH's Harlan, the data "are very provocative. They do bring up the issue of whether if we look only at cholesterol levels we aren't going to miss something very important." De Lorgeril believes the diet's protective effect comes primarily from omega-3 fatty acids, found in seed oils, meat, cereals, green leafy vegetables, and fish, and from antioxidant compounds, including vitamins, trace elements, and flavonoids. He told Science that most researchers and journalists in the field are prisoners of the "cholesterol paradigm." Although dietary fat and serum cholesterol "are obviously connected," he says, "the connection is not a robust one" when it comes to heart disease.

Dietary trade-offs One inescapable reality is that death is a trade-off, and so is diet. "You have to eat something," says epidemiologist Hugh Tunstall Pedoe of the University of Dundee, U.K., spokesperson for the 21-nation Monitoring Cardiovascular Disease Project run by the World Health Organization. "If you eat more of one thing, you eat a lot less of something else. So for every theory saying this disease is caused by an excess in x, you can produce an alternative theory saying it's a deficiency in y." It would be simple if, say, saturated fats could be cut from the diet and the calories with it, but that's not the case. Despite all expectations to the contrary, people tend to consume the same number of calories despite whatever diet they try. If they eat less total fat, for instance, they will eat more carbohydrates and probably less protein, because most protein comes in foods like meat that also have considerable amounts of fat.

This plus-minus problem suggests a different interpretation for virtually every diet study ever done, including, for instance, the kind of metabolic-ward studies that originally demonstrated the ability of saturated fats to raise cholesterol. If researchers reduce the amount of saturated fat in the test diet, they have to make up the calories elsewhere. Do they add polyunsaturated fats, for instance, or add carbohydrates? A single carbohydrate or mixed carbohydrates? Do they add green leafy vegetables, or do they add pasta? And so it goes. "The sky's the limit," says nutritionist Alice Lichtenstein of Tufts University in Boston. "There are a million perturbations."

These trade-offs also confound the kind of epidemiological studies that demonized saturated fat from the 1950s onward. In particular, individuals who eat copious amounts of meat and dairy products, and plenty of saturated fats in the process, tend not to eat copious amounts of vegetables and fruits. The same holds for entire populations. The eastern Finns, for instance, whose lofty heart disease rates convinced Ancel Keys and a generation of researchers of the evils of fat, live within 500 kilometers of the Arctic Circle and rarely see fresh produce or a green vegetable. The Scots, infamous for eating perhaps the least wholesome diet in the developed world, are in a similar fix. Basil Rifkind recalls being laughed at once on this point when he lectured to Scottish physicians on healthy diets: "One said, 'You talk about increasing fruits and vegetable consumption, but in the area I work in there's not a single grocery store.' " In both cases, researchers joke that the only green leafy vegetable these populations consume regularly is tobacco. As for the purported benefits of the widely hailed Mediterranean diet, is it the fish, the olive oil, or the fresh vegetables? After all, says Harvard epidemiologist Dimitrios Trichopoulos, a native of Greece, the olive oil is used either to cook vegetables or as dressing over salads. "The quantity of vegetables consumed is almost a pound [half a kilogram] a day," he says, "and you cannot eat it without olive oil. And we eat a lot of legumes, and we cannot eat legumes without olive oil."

Indeed, recent data on heart disease trends in Europe suggest that a likely explanation for the differences between countries and over time is the availability of fresh produce year-round rather than differences in fat intake. While the press often plays up the French paradox--the French have little heart disease despite seemingly high saturated fat consumption--the real paradox is throughout Southern Europe, where heart disease death rates have steadily dropped while animal fat consumption has steadily risen, says University of Cambridge epidemiologist John Powles, who studies national disease trends. The same trend appears in Japan. "We have this idea that it's the Arcadian past, the life in the village, the utopia that we've lost," Powles says; "that the really protective Mediterranean diet is what people ate in the 1950s." But that notion isn't supported by the data: As these Mediterranean nations became more affluent, says Powles, they began to eat proportionally more meat and with it more animal fat. Their heart disease rates, however, continued to improve compared to populations that consumed as much animal fat but had less access to fresh vegetables throughout the year. To Powles, the antifat movement was founded on the Puritan notion that "something bad had to have an evil cause, and you got a heart attack because you did something wrong, which was eating too much of a bad thing, rather than not having enough of a good thing."

The other salient trade-off in the plus-minus problem of human diets is carbohydrates. When the federal government began pushing low-fat diets, the scientists and administrators, and virtually everyone else involved, hoped that Americans would replace fat calories with fruits and vegetables and legumes, but it didn't happen. If nothing else, economics worked against it. The food industry has little incentive to advertise nonproprietary items: broccoli, for instance. Instead, says NYU's Nestle, the great bulk of the $30-billion-plus spent yearly on food advertising goes to selling carbohydrates in the guise of fast food, sodas, snacks, and candy bars. And carbohydrates are all too often what Americans eat.

Carbohydrates are what Harvard's Willett calls the flip side of the calorie trade-off problem. Because it is exceedingly difficult to add pure protein to a diet in any quantity, a low-fat diet is, by definition, a high-carbohydrate diet--just as a low-fat cookie or low-fat yogurt are, by definition, high in carbohydrates. Numerous studies now suggest that high-carbohydrate diets can raise triglyceride levels, create small, dense LDL particles, and reduce HDL--a combination, along with a condition known as "insulin resistance," that Stanford endocrinologist Gerald Reaven has labeled "syndrome X." Thirty percent of adult males and 10% to 15% of postmenopausal women have this particular syndrome X profile, which is associated with a several-fold increase in heart disease risk, says Reaven, even among those patients whose LDL levels appear otherwise normal. Reaven and Ron Krauss, who studies fats and lipids at Lawrence Berkeley National Laboratory in California, have shown that when men eat high-carbohydrate diets their cholesterol profiles may shift from normal to syndrome X. In other words, the more carbohydrates replace saturated fats, the more likely the end result will be syndrome X and an increased heart disease risk. "The problem is so clear right now it's almost a joke," says Reaven. How this balances out is the unknown. "It's a bitch of a question," says Marc Hellerstein, a nutritional biochemist at the University of California, Berkeley, "maybe the great public health nutrition question of our era."

The other worrisome aspect of the carbohydrate trade-off is the possibility that, for some individuals, at least, it might actually be easier to gain weight on low-fat/high-carbohydrate regimens than on higher fat diets. One of the many factors that influence hunger is the glycemic index, which measures how fast carbohydrates are broken down into simple sugars and moved into the bloodstream. Foods with the highest glycemic index are simple sugars and processed grain products like pasta and white rice, which cause a rapid rise in blood sugar after a meal. Fruits, vegetables, legumes, and even unprocessed starches--pasta al dente, for instance--cause a much slower rise in blood sugar. Researchers have hypothesized that eating high-glycemic index foods increases hunger later because insulin overreacts to the spike in blood sugar. "The high insulin levels cause the nutrients from the meal to get absorbed and very avidly stored away, and once they are, the body can't access them," says David Ludwig, director of the obesity clinic at Children's Hospital Boston. "The body appears to run out of fuel." A few hours after eating, hunger returns.

If the theory is correct, calories from the kind of processed carbohydrates that have become the staple of the American diet are not the same as calories from fat, protein, or complex carbohydrates when it comes to controlling weight. "They may cause a hormonal change that stimulates hunger and leads to overeating," says Ludwig, "especially in environments where food is abundant. ..."

In 1979, 2 years after McGovern's committee released its Dietary Goals, Ahrens wrote to The Lancet describing what he had learned over 30 years of studying fat and cholesterol metabolism: "It is absolutely certain that no one can reliably predict whether a change in dietary regimens will have any effect whatsoever on the incidence of new events of [coronary heart disease], nor in whom." Today, many nutrition researchers, acknowledging the complexity of the situation, find themselves siding with Ahrens. Krauss, for instance, who chairs the AHA Dietary Guidelines Committee, now calls it "scientifically naïve" to expect that a single dietary regime can be beneficial for everybody: "The 'goodness' or 'badness' of anything as complex as dietary fat and its subtypes will ultimately depend on the context of the individual."

Given the proven success and low cost of cholesterol-lowering drugs, most physicians now prescribe drug treatment for patients at high risk of heart disease. The drugs reduce LDL cholesterol levels by as much as 30%. Diet rarely drops LDL by more than 10%, which is effectively trivial for healthy individuals, although it may be worth the effort for those at high risk of heart disease whose cholesterol levels respond well to it.

The logic underlying populationwide recommendations such as the latest USDA Dietary Guidelines is that limiting saturated fat intake--even if it does little or nothing to extend the lives of healthy individuals and even if not all saturated fats are equally bad--might still delay tens of thousands of deaths each year throughout the entire country. Limiting total fat consumption is considered reasonable advice because it's simple and easy to understand, and it may limit calorie intake. Whether it's scientifically justifiable may simply not be relevant. "When you don't have any real good answers in this business," says Krauss, "you have to accept a few not so good ones as the next best thing."

 

Natural Health Newsletter

Randall Neustaedter OMD
Here they go again

Those bad boys at the drug companies are at it again. First they lower the normal cholesterol recommendations from 220 to 200 and then 180. Wow have the sales for Lipitor and other statin-type cholesterol- lowering drugs been soaring. That amounts to a lot of bucks $$$$ for the drug industry, despite all those pesky lawsuits for the deaths caused by Baycol, which was taken off the market. Watch out for those side effects, including liver damage. They can get you faster than cholesterol-related heart disease.

Now a new decree has lowered the numbers for blood pressure as well. Brace yourselves for a barrage of advertisements for blood pressure medications because all of you who thought you had normal blood pressures of 120/80 are now classified with a disease called pre-hypertension as of the announcement on May 15, 2003. You thought 140/90 was the upper limit of normal didn't you? Not anymore. The current recommendation (this week) is to treat anyone with prehypertension and other complicating diseases such as diabetes or kidney problems with drugs. The rest of us can expect to get lectures about losing weight, exercise, and low fat diets.
 

Doctors Appeal to free Innocent Incarcerated "Munchausen" Mom

Roanoke, VA 24014 May 20, 2003

More than five years after her wrongful prosecution for death and injury to her children in 1981-82 a mother remains behind bars in West Virginia for reasons known only to those maintaining injustice under color of law.

Signed by doctors who have examined specimens (some still emerging years post-trial), who know their science and support failure to prosecute initially because both children shared a metabolic disorder, a second appeal for clemency letter from Citizens to Free Marybeth Davis was sent May 15 (2003) to Gov. Wise.

The first letter was mailed Feb. 1, 2002.

"Tegan was not murdered and there was no attempt to murder Seth. The confirmed diagnosis for Tegan is Reyes Syndrome, a condition to which it is now thought she was predisposed by a genetic metabolic (birth) defect. The confirmed diagnosis for Seth is Human Growth Hormone Deficiency (HGHD), formally included under the general name of Leighs Syndrome, a genetic metabolic (birth) defect that causes, amongst other things, reoccurring episodes of hypoglycemia," the correspondence appeal reminds the state's top executive.

Adding a major fact that took years of frustrating effort to find in medical files withheld from defense, the letter reveals "It has also been discovered that Seth suffered brain damage due to lack of oxygen when his endotracheal tube became displaced on the helicopter flight to Pennsylvania.

"However, the courts do not acknowledge the existence of these diagnoses of natural causes made and confirmed by licensed physicians, and they continue year after year with their legal procedures, pretending to be oblivious to the fact that no crimes were committed and that the September 1997 trial was totally in error."

The latest appeal letter and other evidence and court documentation can be found at Click here: Free Marybeth Davis (http://www.freemarybethdavis.homestead.com)

Stating a reasonable conclusion remaining in the aftermath of the stunning 1997 trial result--life without mercy for Marybeth--the letter's next paragraph notes: "Dr. Joseph Aldrich, the attending physician for both Tegan and Seth and an eyewitness, told former Greenbrier County prosecutor, Mark Burnette, prior to the trial, that he and other doctors in 1981-82 had determined that the health problems of the children were due to natural causes and that no murder or attempted murder had been committed.

"From all indications, the former prosecutor simply chose to ignore this information and went to trial knowing that there was no proof that the suspected crimes had been committed. That was either gross stupidity or deliberate wrong doing."

To fast-forward to current events, during his second and ultimately successful bid for election to the West Virginia Senate, former prosecutor Burnette mentioned his success in convicting Marybeth Davis in his electioneering.

Ten months before his belated trial of the stunned mother the prosecutor regaled media which treated the public to emotive speculation about supposed "new evidence." Although the innocent mother was never evaluated for or diagnosed with the still scientifically baseless motivation theory--coined name "Munchausen Syndrome by Proxy"-- it had been accepted by careless courts fairly soon after publication of Dr. Roy Meadow's "Hinterlands" article in August 1977, years prior to the illness and death of the Davis children.

Careful reading of the MSP theory shows Dr. Meadow admitting to saltloading a frequently ill baby in the United Kingdom. The infant always was admitted with high salt levels shown by lab findings. By the doctor's own words his actions were not a standard treatment, not an accident, and not approved or consented research. That is how MSP motivation theory began. It could end in West Virginia if Gov. Wise reads more carefully, than did local prosecutors and the Greenbrier County Court, Sir Roy Meadow's nearly 26-year-old bold confession at: http://web.tiscali.it/humanrights/articles/meadow77.html

Putting in the fewest possible words the prosecution's route to wrongful conviction, the letter continues: "The former prosecutor then convinced an uneducated jury that, contrary to common sense and medical findings, Marybeth had committed murder/attempted murder because she fit the profile for a parent with Munchausen Syndrome By Proxy, a hypothetical and highly controversial psychiatric condition that is not recognized as legitimate by the American Medical Association or the American Psychiatric Association.

"In the final analysis, Marybeth was convicted of committing an imaginary murder (with the amount of caffeine in a cup of coffee as the supposed murder weapon) because she was suspected of having an imaginary psychiatric disorder. The absurdity of this tragedy boggles the mind, and illustrates, once again, that modern medicine and common sense are not a match for ignorance." With the story behind the story still unfolding--just why it appears vital for those with official and personal interests to leave an innocent mother in prison--the letter alludes to the former Illinois governor's freeing wrongly convicted innocents and urges similar action by Gov. Wise.

"More than five years after the trial for crimes that did not happen, the West Virginia Courts refuse to acknowledge that they put an innocent woman in prison whose children suffered from metabolic birth defects. We suspect that the authorities involved are now trying to cover up their mistake by delaying Marybeth's release from prison for as long as possible." "Citizens to Free Marybeth Davis is once again asking that you do that which is morally right, acknowledge the absence of crimes and the existence of the medical diagnoses of natural causes for the alleged victims, and order Marybeth released from prison.

"She is not guilty of poisoning her children because her children were not poisoned. If the Governor of Illinois can order the release of falsely convicted people from prison in his state, you should be able to do the same for a person who was convicted without crimes in West Virginia," the letter concludes. After the tragic death of their daughter and the truly "new evidence" of injury to and more recently the death of their son, Marybeth and her husband adopted a lovely daughter and had a son, today healthy teens. Her attorney--now pressing her case into a third exhausting decade--is Paul Detch of Lewisburg, W. Va.

Barbara Bryan

For more on MSP see also http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=4128
and another mother's story at http://www.expertclick.com/NewsReleaseWire/default.cfm?Action=ReleaseDetail&ID=4172

Barbara Bryan (BHBryan@aol.com)
Communications Director
National Child Abuse Defense & Resource Center
P.O. Box 8323
Roanoke, VA 24014
Phone : 540-345-1952
Fax : 540-345-1899

 

http://story.news.yahoo.com/news?tmpl=story&cid=514&e=20&u=/ap/20030603/ap_o
n_re_us/contaminated_blood_11

Suit Says Drugs Made From Tainted Blood
Tue Jun 3, 2:56 PM ET  Add Top Stories - AP to My Yahoo!

By KIM CURTIS, Associated Press Writer

SAN FRANCISCO - Several hemophiliacs filed a lawsuit against Bayer Corp. and other companies, claiming they exposed patients to HIV (news - web sites) and hepatitis C by selling medicine made with blood from sick, high-risk donors.  The lawsuit alleges the companies continued distributing the blood-clotting product in Asia and Latin America in 1984 and 1985, even after they stopped selling it in the United States because of the known risk of HIV and hepatitis transmission.

The lawsuit filed Monday in federal court seeks class-action status on behalf of thousands of foreign hemophiliacs who received the product, said attorney Robert Nelson. It accuses the companies of negligence and fraudulent concealment. "This is a worldwide tragedy," Nelson said. "Thousands of hemophiliacs have unnecessarily died from AIDS (news - web sites) and many thousands more are infected with HIV or hepatitis C."

Bayer rejected the claims, saying in a statement from its headquarters in Leverkusen, Germany Tuesday that it would examine the lawsuit and prepare its defense.  "Bayer at all times complied with all regulations in force in the relevant countries based on the amount of scientific evidence available at the time," the company said, adding that decisions made 20 years ago should not be judged by today's scientific knowledge.

Nelson said the lawsuit was filed in California because defendant Cutter Biological, now a division of Bayer, was formerly based in Berkeley. Several plasma donation sites also were located in the San Francisco Bay area, he said. The lawsuit was filed less than two weeks after an investigation by The New York Times accused the company of selling old stock of the medicine abroad, while marketing a newer, safer product in the United States.

Bayer told Times it sold the old medicine because some customers doubted the effectiveness of a new version of the product, and because some countries were slow to approve its sale.  While the company said it acted responsibly and in line with the best medical knowledge at the time, Bayer and three other companies that made the concentrate settled 15 years of U.S. lawsuits from people who took the drug, paying about $600 million.

The medicine, called Factor VIII concentrate, can stop or prevent potentially fatal bleeding in people with hemophilia. Early in the AIDS epidemic, the medicine was commonly made using mingled plasma from 10,000 or more donors. Because there was not yet a screening test for HIV, the virus that causes AIDS, thousands of hemophiliacs were infected.

But the lawsuit alleges Bayer and the others refused to take precautions that could have made the product safer. As of 1992, the contaminated blood products had infected at least 5,000 hemophiliacs in Europe with HIV. More than 2,000 had already developed AIDS and 1,250 had died from the disease, the lawsuit said. By the mid-1990s in Japan, hemophiliacs accounted for the majority of the country's 4,000 reported cases of HIV infection and virtually all infections of Japan's hemophiliacs have been linked to contaminated blood products imported from the United States, the lawsuit said.  In Latin America, at least 700 HIV cases are linked to use of contaminated blood products by hemophiliacs, the lawsuit said.
 

http://64.4.26.250/cgi-bin/linkrd?
_lang=EN&lah=e1518f9ea3cd2485682989a1839b1eb4&lat=1052843929&hm___acti
on=http%3a%2f%2fwww%2eobserver%2eco%2euk%2fuk_news%2fstory%2f0%2c6903%
2c915133%2c00%2ehtml

Patients used as drug 'guinea pigs'

Firms pay out millions to doctors to test medicines

Antony Barnett, public affairs editor
Sunday February 9, 2003
The Observer

When Italia Sudano went for a check-up with her GP, Dr Robert Adams, she was in good health. Her husband had died a few months earlier and her blood pressure was a little high. Yet nothing could have prepared Sudano, 72, for the nightmare that was to follow and the discovery of a trail of greed and fraud that went right to the heart of the medical profession.

She was astonished to discover that her trusted GP had been using her as a guinea pig by giving her tablets which had not been medically approved. Worse still, he was being paid to do so by a pharmaceutical company. An investigation by The Observer has revealed that many doctors are risking their patients' health by subjecting them to medical trials without their knowledge.

Sudano's ordeal began when Adams took a blood test and asked her to return the next week. She had been living at Letchworth in Hertfordshire since arriving from Italy 50 years earlier and she  trusted British doctors.

Over the next few weeks Adams asked Sudano to return for more blood tests. By the end of the second month her arms were black and blue. Her son, Joe, said they looked as though they had been slammed in a door. She said: 'At one point I asked if he was selling my blood.' Little did Sudano know how close to the truth her comment was. On her last visit, Adams took a bottle of pills from the top drawer of his desk and suggested Sudano take one a day. While she thought it strange she wasn't being given a prescription, she trusted her doctor.

But within hours of swallowing the pill, she could hardly walk because she was so dazed. Her face had swollen up badly and she was in considerable pain. She stopped taking the tablets and complained to Hertfordshire Health Authority. This sparked an investigation that led to one of the largest cases of medical research fraud ever uncovered in Britain.

It emerged that over the previous five years Adams had earned more  than £100,000 from drug companies, including the European giants AstraZeneca, GlaxoSmithKline and Bayer. They were all paying him to  test their new drugs on his patients. Like Sudano, many of his patients had never given their consent and had no knowledge they were being used as human guinea pigs in a medical trial. Patients with no  symptoms were given drugs and others who needed proper medication were given placebos. Adams was receiving almost £1,000 for each patient.

Last month Adams was found guilty by the General Medical Council (GMC) of serious professional misconduct and suspended for 12 months. The GMC's lawyer described it as 'assault' and Sudano is now looking to sue Adams.

GlaxoSmithKline was using Adams to study its anti-depressant  Paroxetine, but had to cancel the trial at a cost of hundreds of thousands of pounds.

The drugs industry talks of bad apples and the odd errant doctor milking the system but insists that trials using GPs are essential for medical advances and that payment to doctors for the extra work involved is ethically correct.

But an investigation by The Observer suggests the problem of GPs using patients as guinea pigs without their consent is more widespread. Some 3,000 doctors each year are paid by drug firms to  sign up their patients to tests and on average 15 patients are needed for each trial. With doctors picking up £1,000 per patients drug companies are spending £45m on getting doctors onside. There is no  suggestion the companies are implicated in moves to carry out the tests by doctors on patients secretly.

Medical fraud experts estimate that one per cent of all drug trials involve fraud, including failure to get proper consent from patients. This means hundreds of patients a year are being given unapproved and potentially dangerous drugs without their knowledge.

The Observer has discovered that in the last five years the GMC has taken action in a dozen cases involving GPs undertaking fraudulent research. Examples include:

· Dr Vasu Agrawal from Chigwell, Essex, removed samples of womb from menopausal women as part of a trial into a new hormone replacement drug called Divina Nova. Agrawal failed to tell the women they were testing a drug that could have serious side-effects. Agrawal, who forged signatures on consent forms, received almost £6,000 from Orion Pharma International.

· Dr Paul Chima from Edinburgh is estimated to have received more than £200,000 from a range of pharmaceutical companies for testing their new drugs for angina, asthma, high blood pressure and depression. He failed to warn patients of possible side-effects and offered one a £2,000 bribe not to give evidence against him. 

· Dr James Boschler from south London was given £22,500 from Bayer and Solvay Healthcare. He claimed to have signed up 36 patients, but 25 of the consent forms were discovered to be forgeries.

The country's foremost investigator of medical research fraud is Peter Jay, the former Metropolitan Police detective chief inspector who arrested serial killer Dennis Nilsen. Since 1996 Jay has run MedicoLegal Investigations, an independent body, and has taken 12 doctors to the GMC.

Jay is investigating six further cases, including one involving a GP in Manchester. Dr Mark Northfield is alleged not to have obtained consent from patients for entering them into trials to test drugs manufactured by Bayer and Roche to treat high blood pressure and heart problems. Northfield is contesting the allegations before the GMC professional conduct committee.

Jay said: 'While the industry has become more alert to the problems over the last decade there is still clearly a worrying and persistent problem in research fraud involving doctors. This is not just an issue of patient safety, but a problem that might lead to bad drugs being approved or good drugs failing to be approved.'

The Observer's revelations of the continuing problem of research fraud have sparked calls for industry guidelines to be toughened up. David Hinchcliffe, the Labour chair of the House of Commons Health Select Committee, described the situation as bordering on 'scandalous' and said his committee would look into the issue.

He said: 'The relationship between the drug firms and the medical  profession is one that needs to be thoroughly investigated. It is extremely worrying that patients' trust is being abused by doctors who are more interested in making money from the pharmaceutical industry.'

Dr Evan Harris, health spokesman for the Liberal Democrats, suggested that doctors involved in trials should be subject to on-the-spot inspections and that a patient's consent to take part in a drug trial  should be given outside the GP's surgery, for example to a research officer acting for the firm.

Additional research by Charlotte Coulon

antony.barnett@observer.co.uk

 

16 die in hospital 'by mistake': report

11Aug03

SIXTEEN people reportedly died in Victorian hospitals due to medical mistakes last financial year, including a child who was given the wrong medication.  Almost a dozen other people suffered injury due to medical staff treating the wrong patient or body part, instruments being left behind after surgery and neurological damage according to documents The Age has reportedly
obtained.
 
Five more patients reportedly committed suicide in hospital. The deaths and injuries reported to the State Government in 2002-03 - the second year details of such mistakes have been supplied - are regarded as only a small number of those that actually take place.  "It's still a relatively low proportion of the major incidents and deaths that are occurring," said Michael Walsh, chief executive of Bayside Health - which covers hospitals including the Alfred - and deputy chair of the Australian Council for Safety and Quality in Health Care, a body set up in 2000 by federal and state health ministers. "The reality is that hospitals have an appreciable element of risk about them, particularly for folk with complex care needs, who are quite old, and come through the emergency department," he said. Documents detailing the events, obtained under freedom of information laws, did not disclose which hospitals were involved or information that might identify patients, the paper said. This report appears on news.com.au.